Label: PROMETHAZINE HYDROCHLORIDE tablet

  • 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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  • DESCRIPTION
    Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as (±)-10-[2-(Dimethylamino)propyl]phenothiazine monohydrochloride and has the following structural ...
  • 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 tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated ...
  • CONTRAINDICATIONS
    Promethazine 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 ...
  • WARNINGS
    PROMETHAZINE 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 ...
  • 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 depression ...
  • DOSAGE AND ADMINISTRATION
    Promethazine 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 ...
  • HOW SUPPLIED
    Product: 50090-2906 - NDC: 50090-2906-0 1 TABLET in a BLISTER PACK / 33 in a BOX, UNIT-DOSE
  • SPL UNCLASSIFIED SECTION
    Rev. 05-2006M - 7299 - Sandoz Inc. Princeton, NJ 08540
  • Promethazine Hydrochloride
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  • INGREDIENTS AND APPEARANCE
    Product Information