Label: CHILDRENS MUCUS RELIEF COUGH- dextromethorphan hbr, guaifensin liquid

  • NDC Code(s): 24385-985-26
  • Packager: AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385
  • 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 May 27, 2021

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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 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

    anhydrous 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to Children's Mucinex® Cough active ingredients*

    ALCOHOL FREE 

    Children's Mucus Relief

    Cough

    Cough Suppressant (Dextromethorphan HBr)

    Expectorant (Guaifenesin)

    • controls cough
    • relieves chest congestion
    • thins & loosens mucus

    Cherry Flavor

    For Ages 4 to 11 Years

    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 AmerisourceBergen

    1 West First Avenue

    Conshohocken, PA 19428

     www.mygnp.com

  • Package Label

    Dextromethorphan HBr 5 mg, Guaifenesin 100 mg

    GOOD NEIGHBOR PHARMACY Children's Mucus Relief Cough

  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCUS RELIEF  COUGH
    dextromethorphan hbr, guaifensin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-985
    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:24385-985-261 in 1 BOX02/29/2012
    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 finalpart34102/29/2012
    Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 (007914906)
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