Label: ALLERGY- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 33992-0329-1, 33992-0329-7
  • Packager: GREENBRIER INTERNATIONAL, 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 March 2, 2021

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:
      • itchy, watery eyes
      • sneezing
      • runny nose
      • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • sneezing
      • runny nose
  • 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.

  • 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 over1 to 2 tablets
    children 6 to under 12 years1 tablet
    children under 6 yearsdo not use

  • Other information

    • each tablet contains: calcium 30 mg
    • 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

    ASSURED™

    COMPARE TO ACTIVE INGREDIENT OF
    BENADRYL® ALLERGY ULTRATAB® TABLETS*

    Allergy

    • Diphenhydramine HCl 25 mg
    Antihistamine

    Sneezing, Runny Nose, Itchy Throat,
    Itchy, Watery Eyes

    Actual Size

    36 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® Tablets.
    50844             REV1016D32907

    Distributed by:
    Greenbrier International, Inc.
    Chesapeake, VA 23320

    Assured 44-329

    Assured 44-329

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0329
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;329
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0329-71 in 1 CARTON03/02/1990
    136 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:33992-0329-11 in 1 CARTON03/02/1990
    245 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 - GREENBRIER INTERNATIONAL, INC. (610322518)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(33992-0329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(33992-0329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(33992-0329) , PACK(33992-0329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(33992-0329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(33992-0329)