Label: DYE FREE ADULT COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin solution

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

Drug Label Information

Updated April 19, 2024

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  • Active ingredients (in each 20 ml)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 200 mg

    Purposes

    Cough suppressant

    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

    age

    dose

    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 8 mg
    •
    store at room temperature. Do not refrigerate.
  • INACTIVE INGREDIENT

    Inactive ingredients

    anhydrous citric acid, carboxymethyl cellulose sodium, disodium edetate, flavors, glycerin, menthol, potassium citrate, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

  • QUESTIONS

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredients in Dye-Free Sugar-Free Adult Robitussin Cough + Chest Congestion DM*
    NDC 70000-0651-1

    DYE-FREE

    Adult

    Cough+Chest
    Congestion DM

    Dextromethorphan HBr (Cough Suppressant)
    Guaifenesin (Expectorant)

    •
    Controls Cough
    •
    Relieves Chest Congestion
    •
    Thins & Loosens Mucus

    Sugar-Free

    No Added Alcohol
    Specially
    Formulated
    for DIABETICS
    Cherry Menthol Flavor

    For Ages 12 & Over
    8 FL OZ (237 ml)

    *This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark DYE-FREE Sugar-Free Adult Robitussin Cough+chest Congestion DM.

    Distributed by:

    LEADER Dye-Free Adult Cough+Chest Congestion DM 237 ml
  • INGREDIENTS AND APPEARANCE
    DYE FREE ADULT COUGH PLUS CHEST CONGESTION DM 
    dextromethorphan hydrobromide and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0651
    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) GUAIFENESIN200 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)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0651-11 in 1 CARTON04/01/2024
    1237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/01/2024
    Labeler - CARDINAL HEALTH (063997360)
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