Label: KIDS COUGH DAYTIME NIGHTTIME COMBO- dextromethorphan hbr, guaifenesin, chlorpheniramine maleate kit

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

Drug Label Information

Updated February 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Kids' Cough & Chest Congestion

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)

    Dextromethorphan HBr, 5 mg

    Guaifenesin, USP 100 mg

  • PURPOSE

    Purposes

    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.

    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

    • SHAKE WELL before each use
    • 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
    AgeDose
    children 6 to under 12 years5 mL - 10 mL every 4 hours
    children 4 to under 6 years2.5 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, natural flavor, purified water

  • QUESTIONS

    Questions?

    1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark Children's Robitussin® Cough & Chest Congestion DM.

  • SPL UNCLASSIFIED SECTION

    Kids' Nighttime Cough

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 10 mL)

    Chlorpheniramine maleate, USP 2 mg

    Dextromethorphan HBr, USP 15 mg

  • PURPOSE

    Purposes

    Antihistamine

    Cough suppressant

  • INDICATIONS & USAGE

    Uses


    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose • sneezing • itchy, watery eyes

    • itching of the nose or throat

  • WARNINGS

    Warnings

    Do not use


    • to sedate a child or make a child sleepy
    • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have


    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product


    • Do not use more than directed
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    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

    • SHAKE WELL before each use.
    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • do not take more than 4 doses in any 24-hour period
    AgeDose

    Adults and children

    12 years and older

    20 mL every

    6 hours

    Children 6 to under 12

    years

    		10 mL every 6 hours
    Children under 6 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, natural flavor, purified water

  • QUESTIONS

    Questions? 1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    **This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark Children's Robitussin® Nighttime Cough Long-Acting DM.

  • SPL UNCLASSIFIED SECTION

    SHAKE WELL before each use.

    Bottles are safety sealed with a perforated band around bottles. DO NOT use if bottle seals are disturbed or missing.

    Patent Pending | Distributed by: Genexa Inc.

    Atlanta, GA 30324 | genexa.com

    Made in the USA with globally sourced ingredients

    NDC 69676-0090-9

  • PRINCIPAL DISPLAY PANEL

    DAYTIME + NIGHTTIME VALUE PACK

    Genexa®

    MEDICINE MADE CLEAN

    Ages 4+
    Kids' Cough & Chest Congestion

    Dextromethorphan HBr - Cough Suppressant

    Guaifenesin - Expectorant

    Cough

    Mucus

    Chest Congestion

    Made with the same active ingredients as Children's Robitussin® Cough & Chest Congestion DM*

    Medicine made clean

    Same effective active ingredients, but no artificial fillers.

    Organic Blueberry Flavor

    4 fl oz (118 mL)

    Dosing cup included

    Ages 6+

    Long-Acting
    Kids' Nighttime Cough

    Chlorpheniramine Maleate - Antihistamine

    Dextromethorphan HBr - Cough Suppressant

    Relieves Cough up to 8 Hours

    Runny Nose

    Sneezing

    Made with the same active ingredients as Children's Robitussin® Nighttime Cough Long-Acting DM**

    Medicine made clean

    Same effective active ingredients, but no artificial fillers.

    Organic Blueberry Flavor

    4 fl oz (118 mL)

    Dosing cup included

    10064-GNX_CARTON_R-20231018

  • INGREDIENTS AND APPEARANCE
    KIDS COUGH DAYTIME NIGHTTIME COMBO 
    dextromethorphan hbr, guaifenesin, chlorpheniramine maleate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0090
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0090-91 in 1 KIT01/26/2024
    11 in 1 BOTTLE; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BOTTLE, PLASTIC 1 mL  in 5 
    Part 20 BOTTLE 1 mL  in 10 
    Part 1 of 2
    KIDS COUGH AND CHEST CONGESTION 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Item Code (Source)NDC:69676-0037
    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
    WATER (UNII: 059QF0KO0R)  
    CITRUS FRUIT (UNII: XDK00Z8012)  
    AGAVE TEQUILANA STEM (UNII: J026JA743Y)  
    Product Characteristics
    Colorbrown (GOLDEN) Score    
    ShapeSize
    FlavorBLUEBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 DrugM01301/26/2024
    Part 2 of 2
    NIGHTTIME COUGH-KIDS 
    chlorpheniramine maleate, dextromethorphan hbr solution
    Product Information
    Item Code (Source)NDC:69676-0088
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRUS FRUIT (UNII: XDK00Z8012)  
    WATER (UNII: 059QF0KO0R)  
    AGAVE TEQUILANA STEM (UNII: J026JA743Y)  
    Product Characteristics
    Colorbrown (GOLDEN) Score    
    ShapeSize
    FlavorBLUEBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 DrugM01301/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/26/2024
    Labeler - Genexa Inc. (079751024)
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