Observed changes
Oct. 13, 2026, 1:30 a.m.: attachments changed since Oct. 12, 2026, 9:21 a.m..
{'attachments': [{'url': 'https://downloads.regulations.gov/FDA-2026-P-12278-0006/content.pdf', 'body': {'text': '**3.625”**\n\n**0.5”**\n**0.5”**\n\n## 7.75”W\n\n**11”L**\n\n**6.375”**\n\n### Width: 7.75”\n\n### Length: 11.0”\n\n### Fold: 2.75” × 3.875”\n\n## Fold: 2.75” × 3.875” DESCRIPTION\n\n## mg/5 mL 25 Oral Solution, USP\n\n#### Promethazine Hydrochloride Oral Solution, USP 25 mg/5 mL\n\n#### Rx only\n\n#### DESCRIPTION\n\nPromethazine Hydrochloride\n52014\n52014\nPromethazine Hydrochloride\nOral Solution, USP 25 mg/5 mL\n\nEach 5 mL (teaspoonful) of Promethazine HCl Oral Solution contains 25 mg of Promethazine HCl. The \ninactive ingredients present are artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, \nascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C \nBlue No. 1, FD&C Red No. 40, glycerin, sucrose, methylparaben, propylparaben, purified water, saccharin \nsodium, sodium benzoate, and sodium citrate dihydrate.\n\nPromethazine HCl is a racemic compound; the molecular formula is C<sub>17</sub>H<sub>20</sub>N<sub>2</sub>S•HCl and its \nmolecular weight is 320.88.\n\nPromethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-\nethanamine, *N,N,* α-trimethyl-, monohydrochloride, (±)- with the following structural formula:\n\n## $ \\mathrm{C H_{2} C H(CH_{3}) N(CH_{3})_{2}} $\n\nPromethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which \nslowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble \nin alcohol.\n\n#### CLINICAL PHARMACOLOGY\n\nPromethazine is a phenothiazine derivative which differs structurally from the antipsychotic \nphenothiazines by the presence of a branched side chain and no ring substitution. It is thought \nthat this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine \nantagonist properties.\n\nPromethazine is an H<sub>1</sub> receptor blocking agent. In addition to its antihistaminic action, it provides \nclinically useful sedative and antiemetic effects.\n\nPromethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 \nminutes after oral administration and generally last four to six hours, although they may persist as \nlong as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides \nof Promethazine and N-demethylpromethazine are the predominant metabolites appearing in the \nurine.\n\n#### INDICATIONS AND USAGE\n\nPromethazine is useful for:\n\nPerennial and seasonal allergic rhinitis.\n\nVasomotor rhinitis.\n\nAllergic conjunctivitis due to inhalant allergens and foods.\n\nMild, uncomplicated allergic skin manifestations of urticaria and angioedema.\n\nAmelioration of allergic reactions to blood or plasma.\n\n#### Dermographism.\n\nAnaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after \nthe acute manifestations have been controlled.\n\n#### Preoperative, postoperative, or obstetric sedation.\n\nPrevention and control of nausea and vomiting associated with certain types of anesthesia and \nsurgery.\n\nTherapy adjunctive to meperidine or other analgesics for control of post-operative pain.\n\nSedation in both children and adults, as well as relief of apprehension and production of light sleep from \nwhich the patient can be easily aroused.\n\nActive and prophylactic treatment of motion sickness.\n\nAntiemetic therapy in postoperative patients.\n\n#### CONTRAINDICATIONS\n\nPromethazine HCl Oral Solution is contraindicated for use in pediatric patients less than two years \nof age.\n\nPromethazine HCl Oral Solution is contraindicated in comatose states, and in individuals known to be \nhypersensitive or to have had an idiosyncratic reaction to Promethazine or to other phenothiazines.\n\nAntihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms \nincluding asthma.\n\n#### WARNINGS\n\n**Promethazine should not be used in pediatric patients less than 2 years of age because \nof the potential for fatal respiratory depression.**\n\n**Postmarketing cases of respiratory depression, including fatalities, have been reported \nwith use of promethazine in pediatric patients less than 2 years of age. A wide range of \nweight-based doses of promethazine have resulted in respiratory depression in these \npatients.**\n\n**Caution should be exercised when administering promethazine to pediatric patients 2 \nyears of age and older. It is recommended that the lowest effective dose of promethazine \nbe used in pediatric patients 2 years of age and older and concomitant administration of \nother drugs with respiratory depressant effects be avoided.**\n\n#### CNS Depression\n\nPromethazine HCl Oral Solution may impair the mental and/or physical abilities required for the performance \nof potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be \namplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/\nhypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, \nand tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence \nof Promethazine HCl (see **PRECAUTIONS-Information for Patients** and **Drug Interactions).**\n\n#### Respiratory Depression\n\nPromethazine HCl Oral Solution may lead to potentially fatal respiratory depression. Use of Promethazine \nHCl Oral Solution in patients with compromised respiratory function (e.g., COPD, sleep apnea) should \nbe avoided.\n\ndrugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and \nevidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and \ncardiac dysrhythmias).\n\n#### Lower Seizure Threshold\n\nPromethazine HCl Oral Solution may lower seizure threshold. It should be used with caution in \npersons with seizure disorders or in persons who are using concomitant medications, such as \nnarcotics or local anesthetics, which may also affect seizure threshold.\n\n#### Bone-Marrow Depression\n\nPromethazine HCl Oral Solution should be used with caution in patients with bone-marrow depression. \nLeukopenia and agranulocytosis have been reported, usually when Promethazine (Promethazine HCl) \nhas been used in association with other known marrow-toxic agents.\n\n#### Neuroleptic Malignant Syndrome\n\nA potentially fatal symptom complex sometimes referred to as **Neuroleptic Malignant Syndrome** \n(NMS) has been reported in association with Promethazine HCl alone or in combination with antipsychotic\n\nThe diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, \nit is important to identify cases where the clinical presentation includes both serious medical illness \n(e.g. pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal \nsigns and symptoms (EPS). Other important considerations in the differential diagnosis include \ncentral anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) \npathology.\n\nThe management of NMS should include 1) immediate discontinuation of Promethazine HCl, antipsychotic \ndrugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment \nand medical monitoring, and 3) treatment of any concomitant serious medical problems for which \nspecific treatments are available. There is no general agreement about specific pharmacological \ntreatment regimens for uncomplicated NMS.\n\nSince recurrences of NMS have been reported with phenothiazines, the reintroduction of Promethazine \nHCl should be carefully considered.\n\n#### Use in Pediatric Patients\n\n**Promethazine HCl Oral Solution is contraindicated for use in pediatric patients less than \ntwo years of age.**\n\n**Caution should be exercised when administering Promethazine HCl Oral Solution to pediatric \npatients 2 years of age and older because of the potential for fatal respiratory depression.** \n**Respiratory depression and apnea, sometimes associated with death, are strongly associated \nwith Promethazine products and are not directly related to individualized weight-based dosing, \nwhich might otherwise permit safe administration. Concomitant administration of Promethazine \nproducts with other respiratory depressants has an association with respiratory depression, and \nsometimes death, in pediatric patients.**\n\n**Antiemetics are not recommended for treatment of uncomplicated vomiting in pediatric patients, \nand their use should be limited to prolonged vomiting of known etiology. The extrapyramidal \nsymptoms which can occur secondary to Promethazine HCl Oral Solution administration may \nbe confused with the CNS signs of undiagnosed primary disease, e.g., encephalopathy or Reye’s \nsyndrome. The use of Promethazine HCl Oral Solution should be avoided in pediatric patients \nwhose signs and symptoms may suggest Reye’s syndrome or other hepatic diseases.**\n\nExcessively large dosages of antihistamines, including Promethazine HCl Oral Solution, in pediatric \npatients may cause sudden death (see **OVERDOSAGE).** Hallucinations and convulsions have\noccurred with therapeutic doses and overdoses of Promethazine in pediatric patients. In pediatric \npatients who are acutely ill associated with dehydration, there is an increased susceptibility to \ndystonias with the use of Promethazine HCl.\n\n#### Other Considerations\n\nAdministration of Promethazine HCl has been associated with reported cholestatic jaundice.\n\n#### PRECAUTIONS\n\n#### General\n\nDrugs having anticholinergic properties should be used with caution in patients with narrow-angle \nglaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladderneck obstruction.\n\nPromethazine HCl Oral Solution should be used cautiously in persons with cardiovascular disease \nor with impairment of liver function.\n\n#### Information for Patients\n\nPatients should be advised to measure Promethazine HCl Oral Solution with an accurate measuring \ndevice. A household teaspoon is not an accurate measuring device and could lead to overdosage,\nespecially when a half a teaspoon is measured. A pharmacist can recommend an appropriate \nmeasuring device and can provide instructions for measuring the correct dose.\n\nPromethazine HCl Oral Solution may cause marked drowsiness or impair the mental and/or physical \nabilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating \nmachinery. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics \n(including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and \ntranquilizers, may enhance impairment (see **WARNINGS-CNS Depression9** and **PRECAUTIONS-Drug \nInteractions).** Pediatric patients should be supervised to avoid potential harm in bike riding or in other \nhazardous activities.\n\nPatients should be advised to report any involuntary muscle movements.\n\nAvoid prolonged exposure to the sun.\n\n#### Drug Interactions CNS Depressants\n\nPromethazine HCl Oral Solution may increase, prolong, or intensify the sedative action of other \ncentral-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), \nnarcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; \ntherefore, such agents should be avoided or administered in reduced dosage to patients receiving \nPromethazine HCl. When given concomitantly with Promethazine HCl Oral Solution, the dose of \nbarbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced \nby one-quarter to one-half. Dosage must be individualized. Excessive amounts of Promethazine \nHCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; \nthese symptoms usually disappear with adequate control of the pain.\n\n#### Epinephrine\n\nBecause of the potential for Promethazine to reverse epinephrine’s vasopressor effect, epinephrine \nshould NOT be used to treat hypotension associated with Promethazine HCl Oral Solution overdose.\n\n#### Anticholinergics\n\nConcomitant use of other agents with anticholinergic properties should be undertaken with caution.\n\n#### Monoamine Oxidase Inhibitors (MAOI)\n\nDrug interactions, including an increased incidence of extrapyramidal effects, have been reported \nwhen some MAOI and phenothiazines are used concomitantly. This possibility should be considered \nwith Promethazine HCl Oral Solution.\n\n#### Drug/Laboratory Test Interactions\n\nThe following laboratory tests may be affected in patients who are receiving therapy with Promethazine HCl:\n\n#### Pregnancy Tests\n\nDiagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may \nresult in false-negative or false-positive interpretations.\n\n#### Glucose Tolerance Test\n\nAn increase in blood glucose has been reported in patients receiving Promethazine HCl.\n\n#### Carcinogenesis, Mutagenesis, Impairment of Fertility\n\nLong-term animal studies have not been performed to assess the carcinogenic potential of Promethazine, \nnor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of \nfertility with this drug. Promethazine was nonmutagenic in the *Salmonella* test system of Ames.\n\n#### Pregnancy\n\nTeratogenic Effects-Pregnancy Category C\nTeratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 \nmg/kg of Promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum \nrecommended total daily dose of Promethazine for a 50-kg subject, depending upon the indication \nfor which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to \nproduce fetal mortality in rats.\n\nSpecific studies to test the action of the drug on parturition, lactation, and development of the \nanimal neonate were not done, but a general preliminary study in rats indicated no effect on \nthese parameters. Although antihistamines have been found to produce fetal mortality in rodents, \nthe pharmacological effects of histamine in the rodent do not parallel those in man. There are \nno adequate and well-controlled studies of Promethazine HCl Oral Solution in pregnant women.\n\n---\n\n# 7.75”W\n\nPromethazine HCl Oral Solution should be used during pregnancy only if the potential benefit \njustifies the potential risk to the fetus.\n\n#### Nonteratogenic Effects\n\nPromethazine HCl Oral Solution administered to a pregnant woman within two weeks of delivery \nmay inhibit platelet aggregation in the newborn.\n\n#### Labor and Delivery\n\nPromethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor (see \n**DOSAGE AND ADMINISTRATION).** Limited data suggest that use of Promethazine during labor\nand delivery does not have an appreciable effect on the duration of labor or delivery and does \nnot increase the risk of need for intervention in the newborn. The effect on later growth and \ndevelopment of the newborn is unknown. (See also *Nonteratogenic Effects.*)\n\n#### Nursing Mothers\n\nIt is not known whether Promethazine HCl is excreted in human milk. Because many drugs are \nexcreted in human milk and because of the potential for serious adverse reactions in nursing \ninfants from Promethazine HCl Oral Solution, a decision should be made whether to discontinue \nnursing or to discontinue the drug, taking into account the importance of the drug to the mother.\n\n#### Pediatric Use\n\n**Promethazine HCl Oral Solution are contraindicated for use in pediatric patients less than \ntwo years of age** (see **WARNINGS-Black Box Warning and Use in Pediatric Patients).**\n\nPromethazine HCl Oral Solution should be used with caution in pediatric patients 2 years of age and \nolder (see **WARNINGS-Use in Pediatric Patients).**\n\n#### Geriatric Use\n\nClinical studies of Promethazine formulations did not include sufficient numbers of subjects aged \n65 and over to determine whether they respond differently from younger subjects. Other reported \nclinical experience has not identified differences in responses between the elderly and younger \npatients. In general, dose selection for an elderly patient should be cautious, usually starting at the \nlow end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac \nfunction, and of concomitant disease or other drug therapy.\n\nSedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally \nshould be started on low doses of Promethazine HCl Oral Solution and observed closely.\n\n#### ADVERSE REACTIONS\n\n#### Central Nervous System\n\nDrowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; \nconfusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue \nprotrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, \nconvulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.\n\n**Cardiovascular**-Increased or decreased blood pressure, tachycardia, bradycardia, faintness.\n\n**Dermatologic**-Dermatitis, photosensitivity, urticaria.\n\n**Hematologic**-Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.\n\n**Gastrointestinal**-Dry mouth, nausea, vomiting, jaundice.\n\n**Respiratory**-Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially \nfatal). (See **WARNINGS-Respiratory Depression.**)\n\n**Other**-Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been\nreported. (See **WARNINGS-Neuroleptic Malignant Syndrome.**)\n\n#### Paradoxical Reactions\n\nHyperexcitability and abnormal movements have been reported in patients following a single \nadministration of Promethazine HCl. Consideration should be given to the discontinuation of Promethazine \nHCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, \nand agitated behavior have also been reported in some of these patients.\n\n#### OVERDOSAGE\n\nSigns and symptoms of overdosage with Promethazine HCl range from mild depression of the central nervous \nsystem and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and \nsudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensorplantar reflexes (Babinski reflex).\n\nStimulation may be evident, especially in children and geriatric patients. Convulsions may rarely \noccur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to \n125 mg orally, characterized by hyperexcitability and nightmares.\n\nAtropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal \nsymptoms-may occur.\n\n#### Treatment\n\nTreatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage \nor individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and \nEKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or \nmagnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of \nadequate respiratory exchange through provision of a patent airway and institution of assisted \nor controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte \nlosses should be corrected. Note that any depressant effects of Promethazine HCl are not reversed \nby naloxone. Avoid analeptics which may cause convulsions.\n\nThe treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied \nby repositioning if indicated. In the event that vasopressors are considered for the management of \nsevere hypotension which does not respond to intravenous fluids and repositioning, the administration \nof norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since \nits use in patients with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal \nreactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. \nOxygen may also be administered.\n\nLimited experience with dialysis indicates that it is not helpful.\n\n#### DOSAGE AND ADMINISTRATION\n\n*It is important that Promethazine HCl Oral Solution is measured with an accurate measuring device* \n(see **PRECAUTIONS-Information for Patients).** A household teaspoon is not an accurate measuring \ndevice and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly \nrecommended that an accurate measuring device be used. A pharmacist can provide an appropriate \ndevice and can provide instructions for measuring the correct dose.\n\n**Promethazine HCl Oral Solution is contraindicated for children under 2 years of age** (see\n**WARNINGS-Black Box Warning and Use in Pediatric Patients).**\n\n#### Allergy\n\nThe average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals \nand on retiring, if necessary. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily \nwill usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the \nsmallest amount adequate to relieve symptoms. The administration of Promethazine HCl in 25-mg doses \nwill control minor transfusion reactions of an allergic nature.\n\nThe average effective dose of Promethazine for the active therapy of nausea and vomiting in \nchildren or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given \nparenterally (cf. Promethazine Injection) or by rectal suppository. 12.5- to 25-mg doses may be \nrepeated, as necessary, at 4- to 6-hour intervals.\n\n#### Motion Sickness\n\nThe average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour \nbefore anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, \nit is recommended that 25 mg be given on arising and again before the evening meal. For children, \nPromethazine HCl Oral Solution, 12.5 to 25 mg, twice daily, may be administered.\n\nFor nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the \ndose should be adjusted to the age and weight of the patient and the severity of the condition \nbeing treated.\n\nFor prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose \nis 25 mg repeated at 4- to 6-hour intervals, as necessary.\n\n#### Nausea and Vomiting\n\nAntiemetics should not be used in vomiting of unknown etiology in children and adolescents (see \n**WARNINGS-Use in Pediatric Patients).**\n\n#### Sedation\n\nThis product relieves apprehension and induces a quiet sleep from which the patient can be easily \naroused. Administration of 12.5 to 25 mg Promethazine by the oral route will provide sedation in \nchildren. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.\n\n#### Pre- and Postoperative Use\n\nPromethazine in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before \nsurgery relieves apprehension and produces a quiet sleep.\n\nFor preoperative medication, children require doses of 0.5 mg per pound of body weight in combination \nwith an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an \natropine-like drug. Usual adult dosage is 50 mg Promethazine with an appropriately reduced dose \nof narcotic or barbiturate and the required amount of a belladonna alkaloid.\n\nPostoperative sedation and adjunctive use with analgesics may be obtained by the administration \nof 12.5 to 25 mg in children and 25- to 50-mg doses in adults.\n\nPromethazine HCl Oral Solution is contraindicated for children under 2 years of age.\n\n#### HOW SUPPLIED\n\nPromethazine HCl Oral Solution, USP 25 mg/5 mL is a clear, green colored solution available in \nPET plastic bottles as follows:\n\n4 fl oz 4 fl oz (118 mL) NDC 70752-317-06\n8 fl oz (237 mL) NDC 70752-317-15\n\n16 fl oz (473 mL) NDC-70752-317-12\n\n#### STORAGE AND HANDLING\n\n#### Keep tightly closed.\n\n**Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Protect from \nlight. Dispense in light-resistant, tight container.**\n\n#### Manufactured by:\n\n**Quagen Pharmaceuticals LLC**\nWest Caldwell, NJ 07006\n\nRev. 10/26\n\n**Width: 7.75”**\n**Length: 11.0”**\n**Fold: 2.75” × 3.875”**\n\nOral Solution, USP 25 mg/5 mL\nPromethazine Hydrochloride\n52014\n\n**52014**\n**Promethazine Hydrochloride** \n**Oral Solution, USP 25 mg/5 mL**\n\n**6.375”**\n\n3/31/26 1:23\u202fPM 3/31/26 1:23\u202fPM\n\n**3.625”**', 'pages': None, 'truncated': False, 'extraction': 'firecrawl-public-document-markdown', 'request_id': 'cd3719c2-d178-4e96-baf4-40d4c8388133', 'source_url': 'https://downloads.regulations.gov/FDA-2026-P-12278-0006/content.pdf', 'observed_at': '2026-10-12T09:21:41.538907+00:00', 'content_hash': '3a3b55d322c37def1dcdcff0b7ffa5260f5b81e695c12ccbe5a616aad15f1feb'}, 'title': 'pdf', 'check_failed': False}]}{'attachments': [{'url': 'https://downloads.regulations.gov/FDA-2026-P-12278-0006/content.pdf', 'body': {'text': '**3.625”**\n\n**0.5”**\n**0.5”**\n\n## 7.75”W\n\n**11”L**\n\n**6.375”**\n\n### Width: 7.75”\n\n### Length: 11.0”\n\n### Fold: 2.75” × 3.875”\n\n## Fold: 2.75” × 3.875” DESCRIPTION\n\n## mg/5 mL 25 Oral Solution, USP\n\n#### Promethazine Hydrochloride Oral Solution, USP 25 mg/5 mL\n\n#### Rx only\n\n#### DESCRIPTION\n\nPromethazine Hydrochloride\n52014\n52014\nPromethazine Hydrochloride\nOral Solution, USP 25 mg/5 mL\n\nEach 5 mL (teaspoonful) of Promethazine HCl Oral Solution contains 25 mg of Promethazine HCl. The \ninactive ingredients present are artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, \nascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C \nBlue No. 1, FD&C Red No. 40, glycerin, sucrose, methylparaben, propylparaben, purified water, saccharin \nsodium, sodium benzoate, and sodium citrate dihydrate.\n\nPromethazine HCl is a racemic compound; the molecular formula is C<sub>17</sub>H<sub>20</sub>N<sub>2</sub>S•HCl and its \nmolecular weight is 320.88.\n\nPromethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-\nethanamine, *N,N,* α-trimethyl-, monohydrochloride, (±)- with the following structural formula:\n\n## $ \\mathrm{C H_{2} C H(CH_{3}) N(CH_{3})_{2}} $\n\nPromethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which \nslowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble \nin alcohol.\n\n#### CLINICAL PHARMACOLOGY\n\nPromethazine is a phenothiazine derivative which differs structurally from the antipsychotic \nphenothiazines by the presence of a branched side chain and no ring substitution. It is thought \nthat this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine \nantagonist properties.\n\nPromethazine is an H<sub>1</sub> receptor blocking agent. In addition to its antihistaminic action, it provides \nclinically useful sedative and antiemetic effects.\n\nPromethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 \nminutes after oral administration and generally last four to six hours, although they may persist as \nlong as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides \nof Promethazine and N-demethylpromethazine are the predominant metabolites appearing in the \nurine.\n\n#### INDICATIONS AND USAGE\n\nPromethazine is useful for:\n\nPerennial and seasonal allergic rhinitis.\n\nVasomotor rhinitis.\n\nAllergic conjunctivitis due to inhalant allergens and foods.\n\nMild, uncomplicated allergic skin manifestations of urticaria and angioedema.\n\nAmelioration of allergic reactions to blood or plasma.\n\n#### Dermographism.\n\nAnaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after \nthe acute manifestations have been controlled.\n\n#### Preoperative, postoperative, or obstetric sedation.\n\nPrevention and control of nausea and vomiting associated with certain types of anesthesia and \nsurgery.\n\nTherapy adjunctive to meperidine or other analgesics for control of post-operative pain.\n\nSedation in both children and adults, as well as relief of apprehension and production of light sleep from \nwhich the patient can be easily aroused.\n\nActive and prophylactic treatment of motion sickness.\n\nAntiemetic therapy in postoperative patients.\n\n#### CONTRAINDICATIONS\n\nPromethazine HCl Oral Solution is contraindicated for use in pediatric patients less than two years \nof age.\n\nPromethazine HCl Oral Solution is contraindicated in comatose states, and in individuals known to be \nhypersensitive or to have had an idiosyncratic reaction to Promethazine or to other phenothiazines.\n\nAntihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms \nincluding asthma.\n\n#### WARNINGS\n\n**Promethazine should not be used in pediatric patients less than 2 years of age because \nof the potential for fatal respiratory depression.**\n\n**Postmarketing cases of respiratory depression, including fatalities, have been reported \nwith use of promethazine in pediatric patients less than 2 years of age. A wide range of \nweight-based doses of promethazine have resulted in respiratory depression in these \npatients.**\n\n**Caution should be exercised when administering promethazine to pediatric patients 2 \nyears of age and older. It is recommended that the lowest effective dose of promethazine \nbe used in pediatric patients 2 years of age and older and concomitant administration of \nother drugs with respiratory depressant effects be avoided.**\n\n#### CNS Depression\n\nPromethazine HCl Oral Solution may impair the mental and/or physical abilities required for the performance \nof potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be \namplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/\nhypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, \nand tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence \nof Promethazine HCl (see **PRECAUTIONS-Information for Patients** and **Drug Interactions).**\n\n#### Respiratory Depression\n\nPromethazine HCl Oral Solution may lead to potentially fatal respiratory depression. Use of Promethazine \nHCl Oral Solution in patients with compromised respiratory function (e.g., COPD, sleep apnea) should \nbe avoided.\n\ndrugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and \nevidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and \ncardiac dysrhythmias).\n\n#### Lower Seizure Threshold\n\nPromethazine HCl Oral Solution may lower seizure threshold. It should be used with caution in \npersons with seizure disorders or in persons who are using concomitant medications, such as \nnarcotics or local anesthetics, which may also affect seizure threshold.\n\n#### Bone-Marrow Depression\n\nPromethazine HCl Oral Solution should be used with caution in patients with bone-marrow depression. \nLeukopenia and agranulocytosis have been reported, usually when Promethazine (Promethazine HCl) \nhas been used in association with other known marrow-toxic agents.\n\n#### Neuroleptic Malignant Syndrome\n\nA potentially fatal symptom complex sometimes referred to as **Neuroleptic Malignant Syndrome** \n(NMS) has been reported in association with Promethazine HCl alone or in combination with antipsychotic\n\nThe diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, \nit is important to identify cases where the clinical presentation includes both serious medical illness \n(e.g. pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal \nsigns and symptoms (EPS). Other important considerations in the differential diagnosis include \ncentral anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) \npathology.\n\nThe management of NMS should include 1) immediate discontinuation of Promethazine HCl, antipsychotic \ndrugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment \nand medical monitoring, and 3) treatment of any concomitant serious medical problems for which \nspecific treatments are available. There is no general agreement about specific pharmacological \ntreatment regimens for uncomplicated NMS.\n\nSince recurrences of NMS have been reported with phenothiazines, the reintroduction of Promethazine \nHCl should be carefully considered.\n\n#### Use in Pediatric Patients\n\n**Promethazine HCl Oral Solution is contraindicated for use in pediatric patients less than \ntwo years of age.**\n\n**Caution should be exercised when administering Promethazine HCl Oral Solution to pediatric \npatients 2 years of age and older because of the potential for fatal respiratory depression.** \n**Respiratory depression and apnea, sometimes associated with death, are strongly associated \nwith Promethazine products and are not directly related to individualized weight-based dosing, \nwhich might otherwise permit safe administration. Concomitant administration of Promethazine \nproducts with other respiratory depressants has an association with respiratory depression, and \nsometimes death, in pediatric patients.**\n\n**Antiemetics are not recommended for treatment of uncomplicated vomiting in pediatric patients, \nand their use should be limited to prolonged vomiting of known etiology. The extrapyramidal \nsymptoms which can occur secondary to Promethazine HCl Oral Solution administration may \nbe confused with the CNS signs of undiagnosed primary disease, e.g., encephalopathy or Reye’s \nsyndrome. The use of Promethazine HCl Oral Solution should be avoided in pediatric patients \nwhose signs and symptoms may suggest Reye’s syndrome or other hepatic diseases.**\n\nExcessively large dosages of antihistamines, including Promethazine HCl Oral Solution, in pediatric \npatients may cause sudden death (see **OVERDOSAGE).** Hallucinations and convulsions have\noccurred with therapeutic doses and overdoses of Promethazine in pediatric patients. In pediatric \npatients who are acutely ill associated with dehydration, there is an increased susceptibility to \ndystonias with the use of Promethazine HCl.\n\n#### Other Considerations\n\nAdministration of Promethazine HCl has been associated with reported cholestatic jaundice.\n\n#### PRECAUTIONS\n\n#### General\n\nDrugs having anticholinergic properties should be used with caution in patients with narrow-angle \nglaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladderneck obstruction.\n\nPromethazine HCl Oral Solution should be used cautiously in persons with cardiovascular disease \nor with impairment of liver function.\n\n#### Information for Patients\n\nPatients should be advised to measure Promethazine HCl Oral Solution with an accurate measuring \ndevice. A household teaspoon is not an accurate measuring device and could lead to overdosage,\nespecially when a half a teaspoon is measured. A pharmacist can recommend an appropriate \nmeasuring device and can provide instructions for measuring the correct dose.\n\nPromethazine HCl Oral Solution may cause marked drowsiness or impair the mental and/or physical \nabilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating \nmachinery. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics \n(including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and \ntranquilizers, may enhance impairment (see **WARNINGS-CNS Depression9** and **PRECAUTIONS-Drug \nInteractions).** Pediatric patients should be supervised to avoid potential harm in bike riding or in other \nhazardous activities.\n\nPatients should be advised to report any involuntary muscle movements.\n\nAvoid prolonged exposure to the sun.\n\n#### Drug Interactions CNS Depressants\n\nPromethazine HCl Oral Solution may increase, prolong, or intensify the sedative action of other \ncentral-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), \nnarcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; \ntherefore, such agents should be avoided or administered in reduced dosage to patients receiving \nPromethazine HCl. When given concomitantly with Promethazine HCl Oral Solution, the dose of \nbarbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced \nby one-quarter to one-half. Dosage must be individualized. Excessive amounts of Promethazine \nHCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; \nthese symptoms usually disappear with adequate control of the pain.\n\n#### Epinephrine\n\nBecause of the potential for Promethazine to reverse epinephrine’s vasopressor effect, epinephrine \nshould NOT be used to treat hypotension associated with Promethazine HCl Oral Solution overdose.\n\n#### Anticholinergics\n\nConcomitant use of other agents with anticholinergic properties should be undertaken with caution.\n\n#### Monoamine Oxidase Inhibitors (MAOI)\n\nDrug interactions, including an increased incidence of extrapyramidal effects, have been reported \nwhen some MAOI and phenothiazines are used concomitantly. This possibility should be considered \nwith Promethazine HCl Oral Solution.\n\n#### Drug/Laboratory Test Interactions\n\nThe following laboratory tests may be affected in patients who are receiving therapy with Promethazine HCl:\n\n#### Pregnancy Tests\n\nDiagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may \nresult in false-negative or false-positive interpretations.\n\n#### Glucose Tolerance Test\n\nAn increase in blood glucose has been reported in patients receiving Promethazine HCl.\n\n#### Carcinogenesis, Mutagenesis, Impairment of Fertility\n\nLong-term animal studies have not been performed to assess the carcinogenic potential of Promethazine, \nnor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of \nfertility with this drug. Promethazine was nonmutagenic in the *Salmonella* test system of Ames.\n\n#### Pregnancy\n\nTeratogenic Effects-Pregnancy Category C\nTeratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 \nmg/kg of Promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum \nrecommended total daily dose of Promethazine for a 50-kg subject, depending upon the indication \nfor which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to \nproduce fetal mortality in rats.\n\nSpecific studies to test the action of the drug on parturition, lactation, and development of the \nanimal neonate were not done, but a general preliminary study in rats indicated no effect on \nthese parameters. Although antihistamines have been found to produce fetal mortality in rodents, \nthe pharmacological effects of histamine in the rodent do not parallel those in man. There are \nno adequate and well-controlled studies of Promethazine HCl Oral Solution in pregnant women.\n\n---\n\n# 7.75”W\n\nPromethazine HCl Oral Solution should be used during pregnancy only if the potential benefit \njustifies the potential risk to the fetus.\n\n#### Nonteratogenic Effects\n\nPromethazine HCl Oral Solution administered to a pregnant woman within two weeks of delivery \nmay inhibit platelet aggregation in the newborn.\n\n#### Labor and Delivery\n\nPromethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor (see \n**DOSAGE AND ADMINISTRATION).** Limited data suggest that use of Promethazine during labor\nand delivery does not have an appreciable effect on the duration of labor or delivery and does \nnot increase the risk of need for intervention in the newborn. The effect on later growth and \ndevelopment of the newborn is unknown. (See also *Nonteratogenic Effects.*)\n\n#### Nursing Mothers\n\nIt is not known whether Promethazine HCl is excreted in human milk. Because many drugs are \nexcreted in human milk and because of the potential for serious adverse reactions in nursing \ninfants from Promethazine HCl Oral Solution, a decision should be made whether to discontinue \nnursing or to discontinue the drug, taking into account the importance of the drug to the mother.\n\n#### Pediatric Use\n\n**Promethazine HCl Oral Solution are contraindicated for use in pediatric patients less than \ntwo years of age** (see **WARNINGS-Black Box Warning and Use in Pediatric Patients).**\n\nPromethazine HCl Oral Solution should be used with caution in pediatric patients 2 years of age and \nolder (see **WARNINGS-Use in Pediatric Patients).**\n\n#### Geriatric Use\n\nClinical studies of Promethazine formulations did not include sufficient numbers of subjects aged \n65 and over to determine whether they respond differently from younger subjects. Other reported \nclinical experience has not identified differences in responses between the elderly and younger \npatients. In general, dose selection for an elderly patient should be cautious, usually starting at the \nlow end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac \nfunction, and of concomitant disease or other drug therapy.\n\nSedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally \nshould be started on low doses of Promethazine HCl Oral Solution and observed closely.\n\n#### ADVERSE REACTIONS\n\n#### Central Nervous System\n\nDrowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; \nconfusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue \nprotrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, \nconvulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.\n\n**Cardiovascular**-Increased or decreased blood pressure, tachycardia, bradycardia, faintness.\n\n**Dermatologic**-Dermatitis, photosensitivity, urticaria.\n\n**Hematologic**-Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.\n\n**Gastrointestinal**-Dry mouth, nausea, vomiting, jaundice.\n\n**Respiratory**-Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially \nfatal). (See **WARNINGS-Respiratory Depression.**)\n\n**Other**-Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been\nreported. (See **WARNINGS-Neuroleptic Malignant Syndrome.**)\n\n#### Paradoxical Reactions\n\nHyperexcitability and abnormal movements have been reported in patients following a single \nadministration of Promethazine HCl. Consideration should be given to the discontinuation of Promethazine \nHCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, \nand agitated behavior have also been reported in some of these patients.\n\n#### OVERDOSAGE\n\nSigns and symptoms of overdosage with Promethazine HCl range from mild depression of the central nervous \nsystem and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and \nsudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensorplantar reflexes (Babinski reflex).\n\nStimulation may be evident, especially in children and geriatric patients. Convulsions may rarely \noccur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to \n125 mg orally, characterized by hyperexcitability and nightmares.\n\nAtropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal \nsymptoms-may occur.\n\n#### Treatment\n\nTreatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage \nor individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and \nEKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or \nmagnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of \nadequate respiratory exchange through provision of a patent airway and institution of assisted \nor controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte \nlosses should be corrected. Note that any depressant effects of Promethazine HCl are not reversed \nby naloxone. Avoid analeptics which may cause convulsions.\n\nThe treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied \nby repositioning if indicated. In the event that vasopressors are considered for the management of \nsevere hypotension which does not respond to intravenous fluids and repositioning, the administration \nof norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since \nits use in patients with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal \nreactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. \nOxygen may also be administered.\n\nLimited experience with dialysis indicates that it is not helpful.\n\n#### DOSAGE AND ADMINISTRATION\n\n*It is important that Promethazine HCl Oral Solution is measured with an accurate measuring device* \n(see **PRECAUTIONS-Information for Patients).** A household teaspoon is not an accurate measuring \ndevice and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly \nrecommended that an accurate measuring device be used. A pharmacist can provide an appropriate \ndevice and can provide instructions for measuring the correct dose.\n\n**Promethazine HCl Oral Solution is contraindicated for children under 2 years of age** (see\n**WARNINGS-Black Box Warning and Use in Pediatric Patients).**\n\n#### Allergy\n\nThe average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals \nand on retiring, if necessary. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily \nwill usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the \nsmallest amount adequate to relieve symptoms. The administration of Promethazine HCl in 25-mg doses \nwill control minor transfusion reactions of an allergic nature.\n\nThe average effective dose of Promethazine for the active therapy of nausea and vomiting in \nchildren or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given \nparenterally (cf. Promethazine Injection) or by rectal suppository. 12.5- to 25-mg doses may be \nrepeated, as necessary, at 4- to 6-hour intervals.\n\n#### Motion Sickness\n\nThe average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour \nbefore anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, \nit is recommended that 25 mg be given on arising and again before the evening meal. For children, \nPromethazine HCl Oral Solution, 12.5 to 25 mg, twice daily, may be administered.\n\nFor nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the \ndose should be adjusted to the age and weight of the patient and the severity of the condition \nbeing treated.\n\nFor prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose \nis 25 mg repeated at 4- to 6-hour intervals, as necessary.\n\n#### Nausea and Vomiting\n\nAntiemetics should not be used in vomiting of unknown etiology in children and adolescents (see \n**WARNINGS-Use in Pediatric Patients).**\n\n#### Sedation\n\nThis product relieves apprehension and induces a quiet sleep from which the patient can be easily \naroused. Administration of 12.5 to 25 mg Promethazine by the oral route will provide sedation in \nchildren. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.\n\n#### Pre- and Postoperative Use\n\nPromethazine in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before \nsurgery relieves apprehension and produces a quiet sleep.\n\nFor preoperative medication, children require doses of 0.5 mg per pound of body weight in combination \nwith an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an \natropine-like drug. Usual adult dosage is 50 mg Promethazine with an appropriately reduced dose \nof narcotic or barbiturate and the required amount of a belladonna alkaloid.\n\nPostoperative sedation and adjunctive use with analgesics may be obtained by the administration \nof 12.5 to 25 mg in children and 25- to 50-mg doses in adults.\n\nPromethazine HCl Oral Solution is contraindicated for children under 2 years of age.\n\n#### HOW SUPPLIED\n\nPromethazine HCl Oral Solution, USP 25 mg/5 mL is a clear, green colored solution available in \nPET plastic bottles as follows:\n\n4 fl oz 4 fl oz (118 mL) NDC 70752-317-06\n8 fl oz (237 mL) NDC 70752-317-15\n\n16 fl oz (473 mL) NDC-70752-317-12\n\n#### STORAGE AND HANDLING\n\n#### Keep tightly closed.\n\n**Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Protect from \nlight. Dispense in light-resistant, tight container.**\n\n#### Manufactured by:\n\n**Quagen Pharmaceuticals LLC**\nWest Caldwell, NJ 07006\n\nRev. 10/26\n\n**Width: 7.75”**\n**Length: 11.0”**\n**Fold: 2.75” × 3.875”**\n\nOral Solution, USP 25 mg/5 mL\nPromethazine Hydrochloride\n52014\n\n**52014**\n**Promethazine Hydrochloride** \n**Oral Solution, USP 25 mg/5 mL**\n\n**6.375”**\n\n3/31/26 1:23\u202fPM 3/31/26 1:23\u202fPM\n\n**3.625”**', 'pages': None, 'truncated': False, 'extraction': 'firecrawl-public-document-markdown', 'request_id': 'cd3719c2-d178-4e96-baf4-40d4c8388133', 'source_url': 'https://downloads.regulations.gov/FDA-2026-P-12278-0006/content.pdf', 'observed_at': '2026-10-12T09:21:41.538907+00:00', 'content_hash': '3a3b55d322c37def1dcdcff0b7ffa5260f5b81e695c12ccbe5a616aad15f1feb'}, 'title': 'pdf'}]}Collection history starts with our observations; it is not complete legislative amendment history.
Source selection: autonomous systems. Observed 2026-10-13T01:29:06.434968+00:00.
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