Label: ALLERGY MEDICINE- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 15127-018-01, 15127-018-03, 15127-018-24
  • Packager: L&R Distributors, 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 May 6, 2019

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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:
      • 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 over    		 1 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
    • 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, 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

    select brand®
    the lower price name brand

    NDC 15127-018-01

    Allergy Medicine
    Diphenhydramine HCl, 25 mg
    Antihistamine

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

    *Compare to the Active Ingredient of Benadryl® Allergy ULTRATAB® Tablets

    100 MINI-TABS

    Actual Size
    Easy To Swallow  

    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               REV1016C32912

    Distributed by:
    SELECT BRAND® DISTRIBUTORS
    Pine Bluff, AR 71603  USA
    AC (870) 535-3635

    Select Brand 44-329

    Select Brand 44-329

  • INGREDIENTS AND APPEARANCE
    ALLERGY MEDICINE 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-018
    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
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;329
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-018-242 in 1 CARTON03/02/199008/03/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:15127-018-011 in 1 CARTON03/02/199008/03/2021
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:15127-018-031 in 1 PACKAGE03/02/199008/03/2021
    310 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/02/199008/03/2021
    Labeler - L&R Distributors, Inc. (012578514)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(15127-018)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(15127-018)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(15127-018)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(15127-018)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(15127-018) , PACK(15127-018)
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