Label: NIGHTTIME COUGH-KIDS- chlorpheniramine maleate, dextromethorphan hbr solution

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

Drug Label Information

Updated April 25, 2024

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  • SPL UNCLASSIFIED SECTION

    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 USING

    • 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 years

    do 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.

    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 30324 | genexa.com

    Made in the USA with globally sourced ingredients

    NDC 69676-0088-9

  • PRINCIPAL DISPLAY PANEL

    Genexa®

    MEDICINE MADE CLEAN

    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

    Nighttime Cough-Kids

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COUGH-KIDS 
    chlorpheniramine maleate, dextromethorphan hbr solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0088
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 10 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    AGAVE TEQUILANA STEM (UNII: J026JA743Y)  
    WATER (UNII: 059QF0KO0R)  
    CITRUS FRUIT (UNII: XDK00Z8012)  
    Product Characteristics
    Colorbrown (Golden) Score    
    ShapeSize
    FlavorBLUEBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0088-91 in 1 CARTON03/19/2024
    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 DrugM01303/19/2024
    Labeler - Genexa (079751024)
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