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

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 20, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr USP, 5 mg

    Guaifenesin USP, 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 under 6 years 2.5-5 mL every 4 hours
     children under 4 years do not use

  • Other information

    • store between 20-25ºC (68-77ºF).
    • do not refrigerate.
  • Inactive ingredients

    Organic agave syrup, non-GMO citric acid, glycerin, organic natural flavor, purified water

  • QUESTION?

     Call 424-235-0355

  • Principal Display Panel

    KIDS' COUGH & CONGESTION Ages 4-11 yrs

    Dextromethorphan HBr

    5 mg per 5 mL

    Cough Suppressant

    Guaifenesin

    100 mg per 5 mL

    Expectorant

    Organic Berry Flavor

    NO DYES.

    NO ARTIFICIAL FLAVORS.

    NO ARTIFICIAL SWEETENERS.

    DOSAGE CUP PROVIDED

    FL OZ (mL)

    TAMPER EVIDENT:  BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

    Keep outer carton for complete warnings and product information.

    DISTRIBUTED BY: KinderFarms®

    Redondo Beach, CA 90277

    kinderfarms.com

  • Package Label

    Dextromethorphan HBr USP 5 mg Guaifenesin USP, 100 mg

    KINDERMED Kids Cough & Congestion Berry Flavor

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF COUGH AND CONGESTION  CHILDRENS
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82673-102
    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
    AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82673-102-041 in 1 BOX04/29/2022
    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 DrugM01204/29/2022
    Labeler - KinderFarms, LLC (075458767)