Label: CHILDRENS COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide, 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 December 28, 2021

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  • Drug Facts

  • Active Ingredients (in each 5 mL)

    Dextromethorphan HBr, USP, 5mg

    Guaifenesin, USP, 100 mg

    Purpose

    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 make coughs more productive.
  • Warnings

    Do not use

    if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for two 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 giving this product.

    Ask a doctor before use if your child has

    • 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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • do not give more than 6 doses in a 24 hour period.
    • give the recommended number of vials below, following the instructions under How to Open and Use on the side panel.
    • empty all liquid in each Single-Use Vial when dosing.
    Dosing Chart
    Age Dose (mL)
    under 6 years Consult a doctor
    6-11 years 1 -2 Single-Use Vial (5mL) Every 4 hours
    Adults and Children over 12 years 2-4 Single-Use Vial (5mL Each) Every 4 hours

  • Inactive Ingredients

    Citric Acid, Glycerin, Mixed Berry Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Saccharine, Sorbitol, Sucralose, Trisodium Citrate Dihydrate, Xanthan Gum.

  • Other Information

    • each Single-Use Vial contains 8mg of sodium.
    • store at 20-25 °C (68-77 °F).
    • tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken.
  • Questions or Comments?

    1-800-719-9260

  • Package Labeling:

    Package

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COUGH AND CHEST CONGESTION DM 
    dextromethorphan hydrobromide, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-262
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-262-011 in 1 BOX12/04/2018
    1100 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/04/2018
    Labeler - CVS Pharmacy (062312574)