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
  • 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 July 19, 2023

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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 BOX07/11/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:29485-9285-330 in 1 BOX07/11/2016
    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 finalM01207/11/2016
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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