Label: ALLERGIES MY CHILD NEEDS HELP WITH- diphenhydramine hcl tablet, chewable

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

Drug Label Information

Updated October 11, 2023

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  • Active ingredient (in each chewable tablet)

    Diphenhydramine HCl 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • itchy, watery eyes
      • sneezing
      • itching of the nose or throat
  • 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

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination 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
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages
    • excitability may occur, especially in children

    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 (1-800-222-1222) right away.

  • Directions

    • find right dose on chart below
    • chew or crush tablets completely before swallowing; do not swallow tablets whole
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
    Age (yr)Dose (chewable tablets)
    children under 2 yearsdo not use
    children 2 to 5 yearsdo not use unless
    directed by a doctor
    children 6 to 11 years1 to 2 chewable tablets
    (12.5 mg to 25 mg)
    adults and children 12 years and over2 to 4 chewable tablets (25 mg to 50 mg)
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid high humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose

  • Questions or comments?

    1-(888) 860-6888

  • Principal display panel

    TINY
    WELLNESS CO

    6 YEARS &
    OLDER

    Natural
    Flavor

    Dye Free

    MY CHILD NEEDS HELP WITH:
    Allergies

    DIPHENHYDRAMINE HCl, 12.5 mg
    Chewable Tablets / Antihistamine

    4-6 Hour Dose

    Relief for runny nose, sneezing, itchy
    watery eyes, itchy throat or nose.

    Chew or crush tablets completely before swallowing.

    20
    chewable
    tablets

    NATURAL
    GRAPE FLAVOR

    TAMPER EVIDENT:
    DO NOT USE IF
    PACKAGE IS OPENED OR
    IF BLISTER UNIT IS TORN,
    BROKEN OR SHOWS
    ANY SIGNS OF
    TAMPERING

    Distributed by:
    Tiny Wellness Co.
    Los Angeles, CA
    90272

    Questions? Call and ask
    at (888) 860-6888

    50844    ORG091974709

    Tiny Wellness 44-747

    Tiny Wellness 44-747

  • INGREDIENTS AND APPEARANCE
    ALLERGIES  MY CHILD NEEDS HELP WITH
    diphenhydramine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73418-747
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorGRAPE (natural) Imprint Code 44;747
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73418-747-094 in 1 CARTON10/25/2019
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/25/2019
    Labeler - Unconditional Love (081135707)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(73418-747) , pack(73418-747)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(73418-747)
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