Label: ADULT COUGH PLUS CHEST CONGESTION DM WITH HONEY- dextromethorphan hbr, guaifenesin solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 21, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 ml)Purposes

    Dextromethorphan HBr, USP 20 mg

    Cough suppressant

    Guaifenesin, USP 400 mg

    Expectorant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • WARNINGS

    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

    cough that occurs with too much phlegm (mucus)
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding, 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 at 1-800-222-1222.

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than 6 doses in any 24-hour period
    measure only with dosing cup provided
    keep dosing cup with product
    ml = milliliter
    this adult product is not intended for use in children under 12 years of age
    agedose

    adults and children 12 years and over

    20 ml every 4 hours

    children under 12 years

    do not use

  • STORAGE AND HANDLING

    Other information

    each 20 ml contains: sodium 10 mg
    store at room temperature. Do not refrigerate.
  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, honey, natural & artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum, zinc gluconate

  • QUESTIONS

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

    Compare to active ingredients in Robitussin® Honey Cough + Chest Congestion DM MAX*

    NDC 0363-7754-04

    Adult

    Cough + Chest

    Congestion DM

    With Honey

    Dextromethorphan HBr (Cough Suppressant)
    Guaifenesin (Expectorant)

    Maximum Strength

    DM MAX

    Controls Cough
    Relieves Chest Congestion
    Thins & Loosens Mucus
    Gluten Free
    No Artificial Colors
    No Added Alcohol

    Taste the Real Honey

    For Ages 12 & Over

    4 FL OZ (118 ml)

    *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Adult Robitussin® Honey Cough + Chest Congestion DM MAX.

    TAMPER EVIDENT: DON NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

    IMPORTANT: Keep this carton for future reference for full labelling.

    Distributed by:

    WAG Adult Cough+ Chest Congestion DM with Honey
  • INGREDIENTS AND APPEARANCE
    ADULT COUGH PLUS CHEST CONGESTION DM  WITH HONEY
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7754
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7754-041 in 1 CARTON02/05/2024
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/05/2024
    Labeler - WALGREEN COMPANY (008965063)