Label: ALLERGY- diphenhydramine hcl tablet, coated

  • NDC Code(s): 55315-329-07, 55315-329-08
  • Packager: FRED'S, INC.
  • 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 February 23, 2016

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

    • 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 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

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

    • protect from moisture

    • see end flap for expiration date and lot number

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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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  • Principal Display Panel

    FRED'S®

    Allergy Relief
    Antihistamine

    Diphenhydramine HCl

    Relieves
    Sneezing                  
    Runny Nose
    Itchy, Watery Eyes    
    Itchy Throat

    24 Tablets - 25 mg Each

    Compare to the active Ingredient in: Benadryl® Allergy Ultratab®*

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

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®.
    50844      REV0512F32908

    DISTRIBUTED BY: fred's, Inc.
    4300 NEW GETWELL RD, MEMPHIS, TN 38118
    www.fredsinc.com
    Freds 44-329

    Freds 44-329

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  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hcl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-329
    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)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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:55315-329-08 2 in 1 CARTON
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:55315-329-07 3 in 1 CARTON
    2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 03/02/1990
    Labeler - FRED'S, INC. (005866116)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55315-329)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55315-329)
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