Label: CHILDRENS COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    (in each 5 mL)

    Dextromethorphan HBr, USP 5 mg

    Guaifenesin, USP 100 mg

  • PURPOSE

    Purpose

    Cough suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • 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.

    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 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 right away.

    (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions

    • do not give more than 6 doses in any 24-hour period
    • use only with enclosed dose cup. Do not use with any other dosing device.
    • mL = milliliter
    children 6 to under 12 years

    5 mL - 10 mL

    every 4 hours
    children 4 to under 6 years

    2.5 mL - 5 mL

    every 4 hours
    children under 4 yearsdo not use

  • STORAGE AND HANDLING

    Other information

    store between 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    organic agave syrup, organic blueberry flavor, natural citrus extract, flavor, purified water

  • QUESTIONS

    Questions? 1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by PF CONSUMER HEALTHCARE 1 LLC, owner of the registered trademark Children's Robitussin® Cough & Chest Congestion DM.

  • SPL UNCLASSIFIED SECTION

    Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

    Patent Pending | Distributed by: Genexa Inc.

    Atlanta, GA 30318 | genexa.com

  • SPL UNCLASSIFIED SECTION

    Made in the USA with globally sourced ingredients

    NDC 69676-0070-9

  • PRINCIPAL DISPLAY PANEL

    Children's

    Genexa®

    MEDICINE MADE CLEAN

    Ages 4-11

    Cough & Chest Congestion

    Dextromethorphan HBr | Guaifenesin

    Cough Suppressant - Expectorant

    Mucus

    Chest Congestion

    Compare to active ingredients in Children's Robitussin® Cough & Chest Congestion DM*

    How we're different

    Made without: sodium benzoate, propylene glycol, sucralose & more!

    Organic Blueberry Flavor

    4 fl oz (118 mL) Dosing cup included

    GNX-153_Cough-and-Chest-Congestion_Childrens_Carton_R-2022_01_14

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COUGH AND CHEST CONGESTION 
    dextromethorphan hbr, guaifenesin suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0070
    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)  
    WATER (UNII: 059QF0KO0R)  
    CITRUS FRUIT (UNII: XDK00Z8012)  
    BLUEBERRY (UNII: 253RUG1X1A)  
    Product Characteristics
    Colorbrown (Golden) Score    
    ShapeSize
    FlavorBLUEBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0070-91 in 1 CARTON09/01/2022
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/01/2022
    Labeler - Genexa Inc. (079751024)
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