Label: ALLERGY RELIEF- diphenhydramine hcl capsule

  • NDC Code(s): 59779-019-00, 59779-019-12, 59779-019-22, 59779-019-23, view more
    59779-019-51
  • Packager: CVS Pharmacy
  • 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 April 7, 2020

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

  • Active ingredient (in each banded capsule)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • itchy, watery eyes
      • sneezing
      • 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
    • difficulty in urination due to enlargement of the 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 beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    If pregnant of 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 and over
    1 to 2 capsules
    children 6 to under 12
    years
    1 capsule
    children under 6 years
    do not use

  • Other information

    • protect from moisture 
    • TAMPER EVIDENT: PRODUCT SEALED IN PLASTIC STRIPS, CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    ♥CVSHealth™

    Compare to the active
    ingredient in Benadryl®*

    Capsules

    NDC 59779-019-22

    Allergy Relief

    DIPHENHYDRAMINE
    HYDROCHLORIDE, 25 mg

    Antihistamine

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

    48 CAPSULES

    Actual Size

    TAMPER EVIDENT: PRODUCT SEALED IN
    PLASTIC STRIPS, CAPSULE BANDED FOR
    YOUR PROTECTION. DO NOT USE IF
    BLISTER UNIT IS TORN OR BROKEN OR IF
    RED BAND AROUND CAPSULE IS BROKEN
    OR MISSING.

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, owner of the registered
    trademark Benadryl®.
    50844              REV1016A19022

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2017 CVS/pharmacy
    CVS.com®    1-800-SHOP CVS

    V-18615

    CVS® Quality
    Money Back Guarantee

    PLEASE RECYCLE

    CVS Health 44-190

    CVS Health 44-190

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-019
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorPINK, WHITEScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 44;107
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-019-224 in 1 CARTON03/15/1990
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:59779-019-236 in 1 CARTON03/15/199002/22/2018
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:59779-019-002 in 1 CARTON03/15/199001/04/2021
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:59779-019-121 in 1 CARTON03/15/1990
    4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:59779-019-51365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/15/1990
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(59779-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(59779-019) , PACK(59779-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(59779-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(59779-019)