Label: ALLERGY RELIEF- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 55910-329-08, 55910-329-51
  • Packager: DOLGENCORP, LLC
  • 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 April 15, 2020

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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

      • itching of the nose or throat

      • sneezing

    • 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

    • 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

    • use by expiration date on package

    • protect from moisture

  • 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

  • Principal Display Panel

    Since 1903
    Rexall®

    Allergy Relief
    Diphenhydramine HCl 25 mg
    Antihistamine

    Relief of
    • Sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itchy throat

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    50844    REV1016B32951
    Visit us at: Rexall.com or call 1-866-4-REXALL
    MANUFACTURED FOR DOLGENCORP, LLC
    100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA

    Rexall 44-329

    Rexall 44-329

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-329
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    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:55910-329-081 in 1 CARTON03/02/199002/15/2021
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:55910-329-51365 in 1 BOTTLE, PLASTIC; 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 - DOLGENCORP, LLC (068331990)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(55910-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(55910-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(55910-329) , PACK(55910-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(55910-329)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(55910-329)
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