Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

  • 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 November 12, 2021

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  • Drug Facts

    Active ingredient (in each tablet)
    Diphenhydramine HCl 25 mg

  • PURPOSE

    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 (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 37 mg
    ■ Store between 20-25° C (68-77° F). Protect from light.

  • INACTIVE INGREDIENT

    Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Silica, Stearic Acid, Talc, Titanium Dioxide and Triacetin

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy LIQUIGELS®.

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

    RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

    Distributed by:
    CVS Pharmacy, Inc.
    One CVS Drive
    Woonsocket, RI 02895
    © 2020 CVS/pharmacy CVS.com®
    1-800-SHOP CVS
    Product of China
    V-34601

  • PRINCIPAL DISPLAY PANEL

    CVS Health

    Compare to the active ingredient in Benadryl® Allergy LIQUIGELS®*

    Allergy Relief

    Diphehydramine HCl, 25 mg

    Antihistamine

    Relief of: Sneezing; Runny nose; Itchy,watery eyes; Itchy throat

    200 Tablets

    CVS Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-981
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIACETIN (UNII: XHX3C3X673)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code CPC;2824
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-981-081 in 1 CARTON09/23/2020
    1200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/23/2020
    Labeler - CVS Pharmacy, Inc (062312574)
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