Label: PROMETHAZINE HYDROCHLORIDE tablet

  • NDC Code(s): 68382-040-01, 68382-040-05, 68382-040-10, 68382-041-01, view more
  • Packager: Zydus Pharmaceuticals USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 7, 2023

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  • DESCRIPTION
    Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate ...
  • CLINICAL PHARMACOLOGY
    Promethazine 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 ...
  • INDICATIONS AND USAGE
    Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated ...
  • CONTRAINDICATIONS
    Promethazine hydrochloride tablets, USP are contraindicated for use in pediatric patients less than two years of age. Promethazine hydrochloride tablets, USP are contraindicated in comatose ...
  • WARNINGS
    PROMETHAZINE HYDROCHLORIDE TABLETS, USP SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKETING CASES OF ...
  • PRECAUTIONS
    General - Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction ...
  • ADVERSE REACTIONS
    Central Nervous System - Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as ...
  • OVERDOSAGE
    Signs and symptoms of overdosage with promethazine hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory ...
  • DOSAGE AND ADMINISTRATION
    Promethazine hydrochloride tablets, USP 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 ...
  • HOW SUPPLIED
    Promethazine hydrochloride tablets USP, 12.5 mg are white to off-white, round shape, biconvex, uncoated tablets debossed with the logo of "ZC", "01" and bisect on one side and plain on the other ...
  • MEDICATION GUIDE
    Patient Information Leaflet - Promethazine Hydrochloride Tablets, USP - (proe meth′ a zeen hye″ droe klor′ ide) This is a summary of the most important information about promethazine. For details ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Zydus Lifesciences Ltd. India - Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 - Rev.: 09/22
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 68382-040-01 in bottle of 100 tablets - Promethazine Hydrochloride Tablets USP, 12.5 mg - Rx only - 100 tablets - ZYDUS - NDC 68382-041-01 in bottle of 100 tablets - Promethazine Hydrochloride Tablets ...
  • INGREDIENTS AND APPEARANCE
    Product Information