Label: MEIJER CHILDREN COUGH AND CHEST CONGESTION DM GRAPE FLAVOR- dextromethorphan hbr and guaifenesin liquid

  • NDC Code(s): 79481-7470-8
  • Packager: MEIJER DISTRIBUTION INC
  • 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 April 19, 2023

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  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr, USP 20 mg
    Guaifenesin, USP 200 mg

  • Purposes

    Cough suppressant
    Expectorant

  • 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

  • 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 child's 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).

  • 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

     Age

    Dose

    children under 4 years

    do not use

    children 4 to under 6 years

    5 mL every 4 hours

    children 6 to under 12 years

    10 mL every 4 hours

    adults and children 12 years and older

    20 mL every 4 hours
  • Other information

    ▪
    each 20 mL contains: sodium 10 mg
    ▪
    Contains low sodium
    ▪
    store at room temperature. Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

  • Questions or Comments

    1-866-467-2748

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

    COMPARE TO THE CHILDREN'S ROBITUSSIN® COUGH + CHEST CONGESTION DM ACTIVE INGREDIENTS*

    NDC 79481-7470-8
    Meijer  
    CHILDREN'S

    for ages 4 & over

    COUGH+ CHESTCONGESTION DM

    SUGAR FREE

    DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT
    GUAIFENESIN - EXPECTORANT

    Relieves:

    Chest Congestion/ cough & mucus

    GRAPE FLAVOR

    Naturally & Artificially Flavored

    4 FL OZ (118 mL)

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

    IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

    *This product is not manufactured or distributed by Pfizer, the distributor of Children’s Robitussin® Cough & Chest Congestion DM.

    DIST. BY:

    MEIJER DISTRIBUTION, INC

    GRAND RAPIDS, MI 49544

    www.meijer.com

    Meijer Children's Cough & Chest Congestion DM GRAPE FLAVOR

  • INGREDIENTS AND APPEARANCE
    MEIJER CHILDREN COUGH AND CHEST CONGESTION DM  GRAPE FLAVOR
    dextromethorphan hbr and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-7470
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-7470-81 in 1 CARTON03/31/2023
    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 finalpart34103/31/2023
    Labeler - MEIJER DISTRIBUTION INC (006959555)
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