Label: PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE liquid

  • NDC Code(s): 69367-398-16
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 26, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL teaspoonful)Purpose
    Dextromethorphan HBr 7.5 mgAntitussive
    Pyrilamine Maleate 7.5 mgAntihistamine
  • Uses

    temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • cough due to minor throat and bronchial irritation associated with a cold
    • alleviates cough to help you sleep
    • nonnarcotic cough suppressant for the relief of cough
  • Warnings

    Do not exceed recommended dosage.

    • a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

    Do not use this product

    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
    • for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor before use if you are taking sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • sedatives and tranquilizers may increase drowsiness effect
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over:4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor
    Children 6 to under 12 years of age:2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor
    Children under 6 years of age:Consult a doctor
  • Other information

    Store at room temperature 15°C-30°C (59°F-86°F)

  • Inactive ingredients

    Anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

  • Questions or Comments?

    Call 1-844-221-7294 M-F (9 a.m. to 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC: 69367-398-16

    Pyrilamine Maleate
    and
    Dextromethorphan HBr
    Liquid

    Antitussive • Antihistamine

    Sugar Free • Alcohol Free
    • Dye Free • Gluten Free

    Each teaspoonful (5 mL) for oral
    administration contains:

    Dextromethorphan HBr
    7.5 mg

    Pyrilamine Maleate
    7.5 mg

    Candy Apple Flavor

    Tamper evident by foil seal under cap.
    Do not use if foil is broken or missing.

    Supplied in a tight container with a
    child-resistant cap.

    16oz. (473mL)

    Westminster
    Pharmaceuticals

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE 
    pyrilamine maleate and dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-398
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE7.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE (Candy Apple) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-398-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01207/15/2024
    Labeler - Westminster Pharmaceuticals, LLC (079516651)