Label: CHILDRENS MUCUS RELIEF COUGH CHERRY LIQUID- dextromethorphan hbr, guaifensin 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 19, 2022

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  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Guaifenesin 100 mg

  • Purposes

    Cough suppressant

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help your child get to sleep
  • 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 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

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

    Keep out of reach of children.

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

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • shake well before using
    age dose 
     children 6 to under 12 years  5-10 mL every 4 hours 
     children 4 to 5 years 2.5-5 mL every 4 hours
     children under 4 years do not use

  • Other information

    • each 5 mL contains: sodium 2 mg
    • store between 20-25ºC (68-77º). Do not refrigerate.
  • Inactive ingredients

    citric acid, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

  • Questions or comments?

    Call toll free 1-888-423-0139


  • Principal Display Panel

    Compare to Children's Mucinex® Cough active ingredients*

    Children's Cough Mucus Relief

    Dextromethorphan HBr 5 mg - Cough Suppressant

    Guaifenesin 100 mg - Expectorant

    Relieves:

    • cough
    • chest congestion
    • breaks up mucus

    Alcohol Free

    For Ages 4 to 11 Years

    Cherry Flavor

    FL OZ (mL)

    Dosing Cup Included

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

    TAMPER EVIDENT:  DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    Distributed by TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL  60007

    topcare@topco.com  www.topcarebrand.com

  • Package Label

    Dextromethorphan HBr 5 mg, Guaifenesin 100 mg

    Topcare Children's Mucus Relief Cough Cherry Liquid

  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCUS RELIEF COUGH  CHERRY LIQUID
    dextromethorphan hbr, guaifensin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-294
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-294-041 in 1 CARTON04/18/2022
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/18/2022
    Labeler - Topco Associates (006935977)
    Registrant - P & L Development, LLC (079765031)
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