Label: BENADRYL- diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 29485-1007-4, 29485-6931-6, 29485-7963-2, 29485-7963-3
  • Packager: Mechanical Servants, 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 December 14, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
      • sneezing
      • itchy, watery eyes
      • 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
    • trouble urinating due to an enlarged 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 drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful 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. (1-800-222-1222)

  • 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 15 mg
    • store between 20-25°C (68-77°F). Protect from light.
    • do not use if pouch is torn or damaged
  • Inactive ingredients

    carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • Questions or comments?

    call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    McNeil Consumer Healthcare Division
    Fort Washington, PA 19034 USA

    Repackaged and distributed by Convenience Valet ®, Melrose Park, IL 60160

  • PRINCIPAL DISPLAY PANEL - 25 mg Tablet Pouch Package

    Children's
    Miracle Network

    Hospitals ®

    minimum annual
    $250,000
    Donation

    See details on back.

    Benadryl®

    ALLERGY

    Diphenhydramine HCl 25 mg | Antihistamine

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

    ULTRATABS ®*
    *small tablet size

    2 Pouches of 2 Tablets each

    PRINCIPAL DISPLAY PANEL - 25 mg Tablet Pouch Package
  • PRINCIPAL DISPLAY PANEL-25mg Tablet Pouch Package 6ct

    Benadryl ®

    ALLERGY

    Diphenhydramine HCl 25 mg | Antihistamine

    Sneezing
    Itchy, Watery Eyes
    Runny Nose
    Itchy Throat

    ULTRATABS ®*
    *small tablet size

    3 POUCHES OF 2 TABLETS EACH

    Benadryl 6 ct

  • PRINCIPAL DISPLAY PANEL-25mg Tablet Pouch 25 Box

    Benadryl ®

    ALLERGY

    Diphenhydramine HCl 25 mg | Antihistamine

    Sneezing
    Itchy, Watery Eyes
    Runny Nose
    Itchy Throat

    ULTRATABS ®*
    *small tablet size


    25 POUCHES OF 2 TABLETS EACH

    Benadryl 25ct

  • PRINCIPAL DISPLAY PANEL-25mg Tablet Pouch 30 Box

    Benadryl ®

    ALLERGY

    Diphenhydramine HCl 25 mg | Antihistamine

    Sneezing
    Itchy, Watery Eyes
    Runny Nose
    Itchy Throat

    ULTRATABS ®*
    *small tablet size


    30 POUCHES OF 2 TABLETS EACH

    Benadryl 30 ct

  • INGREDIENTS AND APPEARANCE
    BENADRYL 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6931
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code B;WL;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-6931-63 in 1 BLISTER PACK02/06/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/06/2017
    BENADRYL 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7963
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code B;WL;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-7963-225 in 1 BOX07/10/2020
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:29485-7963-330 in 1 BOX10/19/2015
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/19/2015
    BENADRYL 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-1007
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code B;WL;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-1007-42 in 1 PACKAGE09/01/2008
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2008
    Labeler - Mechanical Servants, LLC (005530951)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mechanical Servants, LLC005530951relabel(29485-1007, 29485-6931, 29485-7963) , repack(29485-1007, 29485-6931, 29485-7963)
    Establishment
    NameAddressID/FEIBusiness Operations
    Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divison878046358manufacture(29485-1007, 29485-6931, 29485-7963) , analysis(29485-1007, 29485-6931, 29485-7963) , label(29485-1007, 29485-6931, 29485-7963) , pack(29485-1007, 29485-6931, 29485-7963)