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 November 14, 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)
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