Label: CHILDRENS ALLERGY- diphenhydramine hcl solution

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

Drug Label Information

Updated December 12, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL)

    Diphenhydramine HCl 12.5 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    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 make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to enlargement of the prostate gland

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

    When using this product

    • 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

    If pregnant or breastfeeding, 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

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    • use only with enclosed dose cup. Do not use with any other dosing device.
    adults and children 12 years of age and over10 - 20 mL
    children 6 to under 12 years5 - 10 mL
    children 2 to under 6 yearsdo not use unless directed by a doctor
    children under 2 yearsdo not use

  • STORAGE AND HANDLING

    Other information

    store between 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    organic agave syrup, natural citric extract, purified water

  • QUESTIONS

    Questions?

    1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by

    Johnson & Johnson Corp., owner of the registered

    trademark Children's Benadryl® Allergy Liquid Cherry.

    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 69676-0074-9

  • Children's Allergy

    Children's

    Genexa®

    MEDICINE MADE CLEAN

    Ages 6+

    Allergy

    Diphenhydramine HCl Oral Solution

    12.5 mg per 5 mL | Antihistamine

    Sneezing

    Itchy, Watery Eyes

    Itchy Throat or Nose

    Runny Nose

    Compareto active ingredient in Children’s
    Benadryl® Allergy Liquid Cherry*

    How we're different

    Made without:

    FD&C red no. 40,

    sodium benzoate, sucrose & more!

    Organic Agave Syrup Flavor

    Alcohol Free

    4 FL OZ (118 mL) Dosing cup included

    100A_Allergy_Childrens_Carton_R-20220214

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0074
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
    WATER (UNII: 059QF0KO0R)  
    CITRUS FRUIT (UNII: XDK00Z8012)  
    Product Characteristics
    Colorbrown (Golden) Score    
    ShapeSize
    FlavorHONEY (Organic Agave Syrup Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0074-91 in 1 CARTON04/26/2022
    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 DrugM01304/26/2022
    Labeler - Genexa Inc. (079751024)