Label: ANTIHISTAMINE ALLERGY- diphenhydramine hcl tablet, coated

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 June 14, 2017

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

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

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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

    • temporarily relieves these symptoms due to the common cold:

      • runny nose

      • sneezing

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  • 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
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution 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

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours

    adults and children 12
    years and over

     1 to 2 tablets 
     children 6 to under 12
    years
     1 tablet   
     children under 6 years 
     do not use

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  • Other information

    • each tablet contains: calcium 30 mg
    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • protect from moisture
    • use by expiration date on package
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  • Inactive ingredients

    corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    Compare to Benadryl® Allergy ULTRATAB® active ingredient*

    NDC 37808-329-78

    H-E-B®

    ANTIHISTAMINE ALLERGY
    For Allergy Relief
    Diphenhydramine HCl, 25 mg
    ORG051232908 
    Antihistamine

    • Sneezing    
    • Runny Nose
    • Itchy, watery eyes
    • Itchy throat

    Actual Size

    600 Tablets

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB®.
    50844        ORG101632978       1607

    MADE WITH PRIDE AND CARE FOR
    H-E-B®, SAN ANTONIO, TX 78204

    100%
    GUARANTEE
    promise

    H.E.B 44-329

    H.E.B 44-329

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  • INGREDIENTS AND APPEARANCE
    ANTIHISTAMINE ALLERGY 
    diphenhydramine hcl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-329
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color PINK Score no score
    Shape OVAL Size 11mm
    Flavor Imprint Code 44;329
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-329-08 2 in 1 CARTON 03/02/1990
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:37808-329-78 600 in 1 BOTTLE; Type 0: Not a Combination Product 03/02/1990
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 03/02/1990
    Labeler - H E B (007924756)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(37808-329)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(37808-329)
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