Label: CHILDRENS MUCUS RELIEF COUGH- dextromethorphan hydrobromide, 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 April 1, 2013

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  • Active ingredients

    Drug Facts

    Active ingredients (in each 5 mL teaspoonful)

    Dextromethorphan HBr 5 mg
    Guaifenesin 100 mg

  • Purpose

    Cough suppressant
    Expectorant

  • 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.

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps to loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes
  • 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 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 a pharmacist before taking this product.

  • 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 this product

    • do not use more than directed
  • Stop use and ask a doctor 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.
  • Directions

    • do not take more than 6 doses in any 24-hour period
    AptaPharmaPV ChildMucusRelief1 Label
  • Other information

        each teaspoon contains: sodium 3 mg

    • store between 20-25 ° C (68-77° F)
    • do not refrigerate
    • dosage cup provided
    • Keep carton for full directions for use
  • Inactive ingredients

    citric acid anhydrous, dextrose, D and C Red # 33, FD and C Red # 40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, Xanthan gum

  • Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST

    1-877-798-5944

  • Product Label

    NDC 68016-158-04
    *COMPARE TO THE ACTIVE INGREDIENTS IN CHILDRENS MUCINEX® COUGH

    Premier Value®

    Childrens
    Mucus Relief
    COUGH

    Dextromethorphan HBr ..... Cough Suppressant
    Guaifenesin ..................... Expectorant


    Relieves Chest Congestion
    Thins and Loosens Mucus

    Alcohol Free
    For Ages 4 to 12

    Cherry Flavor

     4 FL OZ (118mL)

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
     

    *This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Mucinex® Cough

    If for Any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

    DISTRIBUTED BY
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON, FL 33431


    BX-015

    AptaPharmaPV ChildMucusRelief Label

  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCUS RELIEF COUGH 
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-158
    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)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-158-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-158)
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