Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride tablet, orally disintegrating

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

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

  • Active ingredient (in each tablet)

     Diphenhydramine HCl 12.5mg

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  • Purpose

     Antihistamine

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  • 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
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  • Warnings

    Do not use

    •  to make a child sleepy
    • with any other products 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 an enlarged 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 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.

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  • Directions

    • dissolve in mouth or chew before swallowing
    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
    children under 2 years of age do not use 
    children 2 to under 6 years of age

    do not use unless directed by a doctor 

    children under 6 to 12 years of age  1 to 2 tablets 
    adults and children 12 years of age  2 to 4 tablets 
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  • Other information

    •  store between 20º-25ºC (68º-86ºF).  Avoid high humidity
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, ethylcellulose polymers, magnesium stearate, mannitol, polytheylene and polypropylene polymers, stearic acid, sucralose

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  • Questions?

     1-888-287-1915

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  • Principal Display Panel

    NDC 49035-599-44

    equate®

    Compare to Children's Benadryl® Allergy FastMelt® Active Ingredient*

    Ages 6+
    Children's
    Allergy Relief
    Diphenhydramine HCl 12.5 mg/Antihistamine

    For the relief of:
    • Sneezing            • Itchy throat
    • Runny Nose       • Itchy, watery eyes

    Cherry Flavor
    18 Rapid Melts

    Distributed by: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716 ©Wal-Mart Stores, Inc.
    **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Benadryl® Allergy FastMelt® .
    50844        ORG011159944

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

    Equate 44-599

    Equate 44-599

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-599
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 27  
    D&C RED NO. 30  
    CHERRY  
    DEXTRATES  
    MAGNESIUM STEARATE  
    MANNITOL  
    SUCRALOSE  
    STEARIC ACID  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 10mm
    Flavor CHERRY Imprint Code 44;599
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-599-44 1 in 1 CARTON
    1 18 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 05/01/2011
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(49035-599)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(49035-599)
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