Label: ALLERGY RELIEF- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 50844-329-02, 50844-329-07, 50844-329-08, 50844-329-12, view more
    50844-329-22, 50844-329-51, 50844-329-82
  • Packager: L.N.K. International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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  • 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
    • 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 right away.

  • Directions

    • do not take more than directed
    • 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 years
    		1 tablet
    children under 6 years
    		do 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • protect from moisture
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, 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

    NDC 50844-329-07

    QUALITY
    + PLUS

    *Compare to active ingredient in
    Benadryl® Allergy ULTRATAB® Tablets

    ALLERGY
    RELIEF
    Diphenhydramine HCl 25 mg
    ANTIHISTAMINE

    Allergy Relief for:
    • Sneezing         • Itchy, Watery Eyes
    • Runny Nose    • Itchy Throat

    36 Minitabs

    ACTUAL SIZE

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

    *This product is not manufactured or distributed by Johnson
    & Johnson Corporation, owner of the registered trademark
    Benadryl® Allergy ULTRATAB® Tablets.
    50844            REV0721G32907

    Distributed by
    LNK INTERNATIONAL, INC.
    60 Arkay Drive
    Hauppauge, NY 11788
    USA

    Quality Plus 44-329

    Quality Plus 44-329

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-329
    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 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;329
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-329-021 in 1 CARTON03/02/1990
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50844-329-082 in 1 CARTON03/02/1990
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:50844-329-073 in 1 CARTON03/02/1990
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:50844-329-224 in 1 CARTON03/02/1990
    412 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:50844-329-12100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/1990
    6NDC:50844-329-51365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/1990
    7NDC:50844-329-821 in 1 CARTON03/02/1990
    7100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/02/1990
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(50844-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(50844-329) , pack(50844-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(50844-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(50844-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(50844-329)
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