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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 27, 2023

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

    Inactive ingredients

    anhydrous citric acid, disodium edetate, FD&C Red No 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • QUESTIONS

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredients in Adult Robitussin® Sugar-Free Cough + Chest Congestion DM*
    NDC 51316-749-08

    SUGAR-FREE

    Adult

    Cough+Chest
    Congestion DM

    Dextromethorphan HBr (Cough Suppressant)
    Guaifenesin (Expectorant)

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


    Specially
    Formulated
    for DIABETICS

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

    Distributed by:

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

    CVS Sugar-Free Adult Cough+Chest Congestion DM 237 ml
  • INGREDIENTS AND APPEARANCE
    CVS SUGAR FREE ADULT COUGH PLUS CHEST CONGESTION DM 
    dextromethorphan hydrobromide and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-749
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-749-081 in 1 CARTON07/10/2023
    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 finalpart34107/10/2023
    Labeler - CVS PHARMACY (062312574)
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