Label: ALLERGY RELIEF- diphenhydramine hcl capsule

  • NDC Code(s): 70677-0002-1, 70677-0002-2
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2023

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  • 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 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.

  • 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

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • protect from moisture
    • 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?

    Call 833-358-6431 Monday-Friday 9:00 AM-7:00 PM EST

  • Principal Display Panel

    sunmark®

    COMPARE TO BENADRYL® ALLERGY
    ACTIVE INGREDIENT*
    NDC 70677-0002-2

    allergy relief
    DIPHENHYDRAMINE HCl, 25 mg
    Antihistamine

    For Relief Of
    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat

    ACTUAL
    SIZE

    100 CAPSULES

    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

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, owner of the registered
    trademark Benadryl® Allergy.
    50844       ORG111719012

    Distributed by McKesson Corp.,
    via Strategic Sourcing Services LLC,
    Memphis, TN 38141
    © 2003 McKesson Corporation
    Please visit us at www.sunmarkbrand.com
    Money Back Guarantee

    Sunmark 44-190

    Sunmark 44-190

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0002
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorpink, whiteScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 44;107
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-0002-21 in 1 CARTON11/19/2022
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:70677-0002-12 in 1 CARTON03/15/199006/08/2022
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/15/199001/16/2025
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(70677-0002)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(70677-0002)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(70677-0002) , pack(70677-0002)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(70677-0002)
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