Label: CHILDRENS MUCUS RELIEF CHEST CONGESTION PLUS COUGH- dextromethorphan hbr, guaifenesin liquid

  • 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 11, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)
    Dextromethorphan HBr                  5mg
    Guaifenesin                              100 mg

  • PURPOSE

    Purpose
    Dextromethorphan HBr ...................... Cough suppressant
    Guaifenesin....................................... Expectorant

  • INDICATIONS & USAGE

  • WARNINGS

    Warnings
    Do not use in a child who is 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 giving this product.

  • ASK DOCTOR

    Ask a doctor before use if the child has
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with asthma

  • WHEN USING

    When using this product • do not use more than directed

  • STOP USE

    Stop use and ask adoctor if • cough lasts more than 7 days,
    comes back, or occurs with fever, rash, or persistent headache.
    These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical
    help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than 6 doses in any 24-hour period
    • mL = milliliter
    Age                                   Dose

     Children 6 years to under

     12 years

     5 mL - 10 mL

     every 4 hours

     Children under 6 years Do not use

  • OTHER SAFETY INFORMATION

    Other information
    • each 5mL contains: sodium 3mg
    • store between 20-25°C (68-77°F)
    • do not refrigerate
    • dosing cup provided

  • INACTIVE INGREDIENT

    Inactive ingredients
    Anhydrous citric acid, flavors, purified water, sodium benzoate, sucrose

  • QUESTIONS

    Ouestions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

  • Principal Display Panel

    CVS
    HealthTM

    Compare to the
    active ingredients in
    Children's Mucinex® Cough*

    Children's
    Mucus Relief
    Chest Congestion
    Plus Cough

    Free of alcohol, dyes &
    artificial sweeteners

    DEXTROMETHORPHAN HBr
    Cough suppressant

    GUAIFENESIN
    Expectorant

    Relieves:
    Chest congestion & cough
    Thins & loosens mucus

    Cherry Flavor

    For Ages
    6 to 12 Years

    8 FL OZ (237 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    DO NOT REFRIGERATE. STORE AT ROOM TEMPERATURE.

    *This product is not manufactured or distributed by Reckitt
    Benckiser, distributor of Children's Mucinex® Cough.

    Lot:
    Exp:

    LR-113 REV 01 #338883

    0 50428 61752 6

    DRUG FACTS→
    CONTINUED
    ON BACK

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    ↓Product Package↓

    image description

    Children's Mucus Relief Chest Congestion Plus Cough by CVS Pharmacy, Inc.

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCUS RELIEF CHEST CONGESTION PLUS COUGH 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-314
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-314-26237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-314)