Label: PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride solution
- NDC Code(s): 29033-500-34
- Packager: Nostrum Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 12, 2025
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SPL UNCLASSIFIED SECTIONRx only
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DESCRIPTIONEach teaspoonful (5 mL) of Promethazine HCl Oral Solution contains 6.25 mg promethazine HCl in a flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The inactive ingredients present are ...
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CLINICAL PHARMACOLOGYPromethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that ...
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INDICATIONS AND USAGEPromethazine HCl Oral Solution is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated ...
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CONTRAINDICATIONSPromethazine HCl Oral Solution is contraindicated for use in pediatric patients less than two years of age. Promethazine HCl Oral Solution is contraindicated in comatose states, and in individuals ...
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WARNINGSPromethazine HCl Oral Solution should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of ...
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PRECAUTIONSGeneral - Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction ...
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ADVERSE REACTIONSCentral Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness, confusion, disorientation, and extrapyramidal symptoms such as ...
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OVERDOSAGESigns and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression ...
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DOSAGE AND ADMINISTRATIONIt is important that Promethazine HCl Oral Solution is measured with an accurate measuring device (see PRECAUTIONS-Information for Patients). A household teaspoon is not an accurate measuring ...
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HOW SUPPLIEDPromethazine Hydrochloride Oral Solution USP, 6.25 mg/5 mL, is a clear, green oral solution supplied as follows: NDC 29033-500-34 Bottle of 16 fl. oz. (473 mL) with a child-resistance ...
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SPL UNCLASSIFIED SECTIONManufactured by: Nostrum Laboratories, Inc. Bryan, OH 43506 - 5976T07 Iss. 11/23
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PATIENT INFORMATION LEAFLETPROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, 6.25 mg per 5 mL) Rx Only - What Is Promethazine HCl Oral Solution? Promethazine is an ...
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PACKAGE LABEL-PRINCIPAL DISPLAY PANELNDC 29033-500-34 - Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL - (Promethazine Hydrochloride Syrup, 6.25 mg per 5 mL) Alcohol 7% v/v - 16 fl oz (473 mL) Rx Only
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INGREDIENTS AND APPEARANCEProduct Information