Label: ALLERGY RELIEF- diphenhydramine hcl 25 mg tablet, film coated

  • NDC Code(s): 29485-9285-2, 29485-9285-3, 29485-9285-4
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 19, 2024

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  • Drug Facts

  • Active Ingredient

    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 tranquilizers or sedatives.

    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 doses in 24 hours

    adults and children 12 years and over

    		take 1 to 2 tablets
    children 6 to under 12 yearstake 1 tablet
    children under 6 yearsdo not use
  • Other Information

    • each tablet may contain: calcium 25 mg
    • store at room temperature 68°-77°F (20°-25°C)
    • protect from light and moisture
  • Inactive Ingredients

    carnauba wax 1 , colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate 1 , hypromellose, lactose 1 , magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 1 , titanium dioxide

    1
    may contain
  • Questions or Comments

    call toll-free 800-351-2000 (M-F 8:00 AM-4:30 PM CST)

  • SPL UNCLASSIFIED SECTION

    * This product is not manufactured or distributed by

    JOHNSON & JOHNSON CONSUMER INC,

    McNeil Consumer Healthcare Division,

    distributor of Benadryl® Allergy ULTRATABS®

    Distributed by:

    Lil’ Drug Store Products, Inc.

    Cedar Rapids, IA 52404

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO THE ACTIVE INGREDIENTS IN

    Benadryl® Allergy ULTRATABS®

    Allergy Relief

    Diphenhydramine HCl 25 mg,

    Antihistamine

    Relieves Symptoms of

    Hay Fever, Common Cold and [tablet image here]

    Other Upper Respiratory Allergies actual size

    2 TABLETS IN EACH PACKET

    Allergy Relief 2 tablets in each Packet

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl 25 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-9285
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 048;D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-9285-225 in 1 BOX07/11/201606/18/2027
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:29485-9285-330 in 1 BOX07/11/201603/28/2027
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:29485-9285-450 in 1 BOX07/11/2016
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/11/2016
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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