Label: ALLERGY- diphenhydramine hcl capsule

  • NDC Code(s): 49614-462-62, 49614-462-78
  • Packager: Medicine Shoppe International Inc
  • 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 December 7, 2017

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
      • 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 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 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 over1 to 2 capsules
    children 6 to under 12 years of age1 capsule
    children under 6 years of agedo not use this product in children under 6 years of age


  • Other information

    • store at controlled room temperature 15º-30ºC (59º-86ºF)
    • 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, magnesium stearate, methylparaben, propylparaben, polysorbate 80, silica gel

  • Principal Display Panel

    The Medicine
    Shoppe®

    NDC 49614-462-78

    MAY CAUSE DROWSINESS

    ALLERGY
    Antihistamine
    Diphenhydramine HCl

    • Sneezing            • Itchy, Watery Eyes
    • Runny Nose       • Itchy Throat

    COMPARE TO BENADRYL®
    active ingredient*

    100%
    SATISFACTION
    GUARANTEED

    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
    McNeil Consumer Healthcare, owner of the registered
    trademark Benadryl®.
    50844          REV0810F19012

    Distributed by
    Medicine Shoppe International, Inc.
    Earth City, MO 63045
    www.medicineshoppe.com
    A Cardinal Health Company
    CIN 2811792         1-800-325-1397

    MEDICINE SHOPPE® GUARANTEE
    IF YOU ARE NOT FULLY SATISFIED
    WITH THIS PRODUCT, SIMPLY RETURN
    THE UNUSED PORTION FOR REPLACEMENT
    OR FULL REFUND OF PURCHASE PRICE.

    Medicine Shoppe 44-190

    Medicine Shoppe 44-190

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49614-462
    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)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    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)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 44;107
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49614-462-621 in 1 CARTON03/15/199008/27/2018
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49614-462-781 in 1 CARTON03/15/199012/07/2020
    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 FINALpart34103/15/199012/07/2020
    Labeler - Medicine Shoppe International Inc (071997654)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(49614-462)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(49614-462) , PACK(49614-462)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(49614-462)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(49614-462)