Label: ALLERGY RELIEF- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 41250-329-08, 41250-329-12, 41250-329-22, 41250-329-51
  • Packager: Meijer Distribution 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 13, 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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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 years do not use
  • Other information

    • each tablet contains: calcium 30 mg 
    • protect from moisture
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • use by expiration date on package
  • 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

    VALUE SIZE
    365 TABLETS

    NDC 41250-329-51

    Compare to Benadryl® Allergy ULTRATAB®active Ingredient*

    meijer®

    Allergy Relief

    Diphenhydramine HCl | 25 mg
    Antihistamine

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

    365 Tablets

    Actual Size

    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®.
    50844           REV1016B32951

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544
    www.meijer.com

    Meijer 44-329

    Meijer 44-329

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-329
    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)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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:41250-329-224 in 1 CARTON03/02/199003/29/2019
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41250-329-082 in 1 CARTON03/02/199003/29/2019
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41250-329-121 in 1 CARTON03/02/199003/29/2019
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41250-329-51365 in 1 BOTTLE; Type 0: Not a Combination Product03/02/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/02/1990
    Labeler - Meijer Distribution Inc (006959555)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(41250-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(41250-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(41250-329) , PACK(41250-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(41250-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(41250-329)