Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • NDC Code(s): 69842-825-00, 69842-825-12, 69842-825-22, 69842-825-51
  • Packager: CVS Pharmacy, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 May 20, 2020

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  • Drug Facts

    Active ingredient (in each banded capsule)

    Diphenhydramine HCI 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 (1-800-222-1222) right away.

  • Directions

    • take every 4 to 6 hours 
    • do not take more than 6 doses in 24 hours

    adults and children 12 years of age and over

    1 to 2 capsules

    children 6 to under 12 years of age

    1 capsule

    children under 6 years of age

    do not use this product in children under 6 years of age

  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 
    • protect from moisture 
    • see end flap for expiration date and lot number
  • Inactive ingredients

    D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

    RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Benadryl®.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2018 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-34601

  • PRINCIPAL DISPLAY PANEL

    CVSHealth

    Compare to the active ingredient in Benadryl®*

    Allergy Relief

    DIPHENHYDRAMINE HYDROCHLORIDE,

    25 mg - Antihistamine

    Relief of:

    Sneezing, Runny nose,

    Itchy, watery eyes, Itchy throat

    365 CAPSULES

    CVS Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-825
    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
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorpink (Half pink and Half clear with white powder inside) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-825-002 in 1 CARTON06/20/2018
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69842-825-224 in 1 CARTON06/20/2018
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:69842-825-121 in 1 CARTON06/20/2018
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69842-825-51365 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/20/2018
    Labeler - CVS Pharmacy, Inc. (062312574)
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