Label: PROMETHAZINE HYDROCHLORIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-2906-0 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0781-1830
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 29, 2018
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- Official Label (Printer Friendly)
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DESCRIPTIONPromethazine hydrochloride, a phenothiazine derivative, is designated chemically as (±)-10-[2-(Dimethylamino)propyl]phenothiazine monohydrochloride and has the following structural ...
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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 hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated ...
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CONTRAINDICATIONSPromethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age. Promethazine is contraindicated in comatose states, and in individuals known to be ...
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WARNINGSPROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POST-MARKETING CASES OF RESPIRATORY ...
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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 hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression ...
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DOSAGE AND ADMINISTRATIONPromethazine hydrochloride tablets are contraindicated for children under 2 years of age (see WARNINGS: Black Box Warning and Use in Pediatric Patients). Allergy - The average oral dose is 25 ...
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HOW SUPPLIEDProduct: 50090-2906 - NDC: 50090-2906-0 1 TABLET in a BLISTER PACK / 33 in a BOX, UNIT-DOSE
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SPL UNCLASSIFIED SECTIONRev. 05-2006M - 7299 - Sandoz Inc. Princeton, NJ 08540
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Promethazine Hydrochloride
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INGREDIENTS AND APPEARANCEProduct Information