Label: ALLERGY RELIEF- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 63940-329-03, 63940-329-08, 63940-329-12
  • Packager: Harmon Store 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 October 7, 2020

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

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 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
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing 
  • 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
    • avoid alcoholic beverages
    • 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. 

  • 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 yearsdo not use

  • Other information

    • each tablet contains: calcium 30 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from moisture
    • see end flap for expiration date and lot number 
  • 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 

  • Questions or comments?

    1-800-426-9391 

  • Principal Display Panel

    CORE VALUES™

    Compare to active ingredient in
    Benadryl® Allergy ULTRATAB®

    NDC 63940-329-03

    Allergy Relief

    Diphenhydramine HCl 25 mg 
    Antihistamine

    Relieves:
    •Sneezing
    •Itchy Throat
    •Runny Nose
    •Itchy, Watery Eyes

    Actual Size

    24 coated mini-tabs

    Easy to Swallow

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

    50844       REV1016A32908

    Distributed by: Liberty Procurement Inc.,
    650 Liberty Ave., Union NJ 07083 U.S.A.
    Satisfaction Guaranteed Or Your Money Back
    Visit us at www.facevalues.com

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

    Core Values 44-329

    Core Values 44-329

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-329
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;329
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-329-082 in 1 CARTON03/02/1990
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63940-329-031 in 1 PACKAGE03/02/1990
    210 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:63940-329-121 in 1 CARTON03/02/1990
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/02/1990
    Labeler - Harmon Store Inc. (804085293)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(63940-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(63940-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(63940-329) , PACK(63940-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(63940-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(63940-329)