Label: ALLERGY RELIEF- diphenhydramine hcl capsule

  • NDC Code(s): 70677-1015-1, 70677-1015-2
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 12, 2024

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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

    • TAMPER EVIDENT: 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 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 to Friday 9:00am to 7:00pm EST

  • Principal Display Panel

    NDC 70677-1015-1

    COMPARE TO BENADRYL® ACTIVE INGREDIENT*

    Foster & Thrive ™

    Allergy Relief

    Diphenhydramine HCl, 25 mg
    ANTIHISTAMINE

    Relief of:
         • Sneezing
     • Runny Nose
     • Itchy Throat
     • Itchy, Watery Eyes

    ACTUAL SIZE

    24 CAPSULES

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED
    OR 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 Kenvue Inc.,
    owner of the registered trademark Benadryl®.
    50844 REV1117A19008    Rev.11/23

    ©2023 McKesson Corporation

    Distributed by: McKesson Corp., via Strategic
    Sourcing Services LLC., Memphis, TN 38141
    Money Back Guarantee
    www.fosterandthrive.com

    Foster & Thrive 44-190

    Foster & Thrive 44-190

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1015
    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:70677-1015-12 in 1 CARTON04/06/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70677-1015-21 in 1 CARTON04/10/2023
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/06/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(70677-1015, 70677-1015)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(70677-1015, 70677-1015)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(70677-1015, 70677-1015)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(70677-1015, 70677-1015)
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