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 SECTION
    Rx only
  • DESCRIPTION
    Each 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 ...
  • 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 HCl Oral Solution is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated ...
  • CONTRAINDICATIONS
    Promethazine 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 ...
  • WARNINGS
    Promethazine 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 ...
  • 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 HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression ...
  • DOSAGE AND ADMINISTRATION
    It 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 ...
  • HOW SUPPLIED
    Promethazine 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 ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Nostrum Laboratories, Inc. Bryan, OH 43506 - 5976T07 Iss. 11/23
  • PATIENT INFORMATION LEAFLET
    PROMETHAZINE 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 ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL
    NDC 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
  • INGREDIENTS AND APPEARANCE
    Product Information