Label: WESTUSSIN DM- dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup

  • NDC Code(s): 69367-334-16
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 23, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL teaspoonful)Purpose
    Dexchlorpheniramine Maleate 1 mgAntihistamine
    Dextromethorphan HBr 10 mgCough Suppressant
    Phenylephrine HCl 5 mgNasal Decongestant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
    • temporarily relieves nasal congestion due to the common cold, hay fever or other respiratory allergies
    • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • runny nose
    • sneezing
    • itching of the nose of throat
    • itchy, watery eyes
    • temporarily restores freer breathing through the nose
  • Warnings

    Do not use 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

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • cough accompanied by excessive phlegm (mucus)

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

    When using this product

    • do not exceed recommended dosage
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur especially in children

    Stop use and ask a doctor if

    • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
    • symptoms do not improve within 7 days or are accompanied by fever
    • nervousness, dizziness, or sleeplessness occur

    If pregnant or breastfeeding ask a health professional before use

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults 12 and over: 10 mL every 4 hours Not to exceed 60 mL in 24hrs
    Children 6-12:5 mL every 4 hours Not to exceed 30 mL in 24hrs
    Children 2-6:Consult a doctor
  • Other information

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

  • Inactive ingredients

    Citric acid anhydrous, cotton candy flavoring, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

  • Questions?

    Call weekdays from 9 AM to 5 PM EST at 1-844-221-7294. You may also report serious side effects to this phone number.

  • PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

    NDC 69367-334-16

    WesTussin DM

    Antihistamine • Cough Suppressant
    Nasal Decongestant
    • Alcohol Free • Dye Free
    • Sugar Free • Gluten Free

    Each 5 mL (1 teaspoonful) contains:
    Dexchlorpheniramine Maleate
    1 mg
    Dextromethorphan HBr
    10 mg
    Phenylephrine HCl
    5 mg

    Cotton Candy Flavor

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

    16 oz (480 mL)

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    WESTUSSIN DM 
    dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-334
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 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
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-334-16480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01207/29/2021
    Labeler - Westminster Pharmaceuticals, LLC (079516651)
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