Label: ALLERGY MEDICINE- diphenhydramine hcl capsule

  • NDC Code(s): 15127-283-12, 15127-283-24, 15127-283-48
  • Packager: L&R Distributors, 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 October 13, 2018

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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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 children12 years and over

    1 to 2 capsules
    children 6 to under 12 years
    1 capsule
    children under 6

    do not use

  • Other information

    • 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 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?

    1-800-426-9391

  • Principal Display Panel

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    the lower price name brand

    NDC 15127-283-48

    Allergy Medicine
    Diphenhydramine HCl, 25 mg
    Antihistamine

                  Allergy Relief For:
    Sneezing                        Runny Nose
    Itchy, Watery Eyes          Itchy Throat

    *Compare to the Active Ingredient of Benadryl®

    48 CAPSULES

    Actual Size
    Each capsule individually
    banded for your protection

    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       REV1016C19022

    Satisfaction Guaranteed
    select brand®

    Distributed by:
    SELECT BRAND® DISTRIBUTORS
    Pine Bluff, AR 71603  USA
    AC (870) 535-3635

    Select Brand 44-190

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  • INGREDIENTS AND APPEARANCE
    ALLERGY MEDICINE 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-283
    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 (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)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorPINK, WHITEScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 44;107
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-283-242 in 1 CARTON03/15/199009/10/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:15127-283-484 in 1 CARTON03/15/199009/10/2021
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:15127-283-12100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/199009/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/15/199009/10/2021
    Labeler - L&R Distributors, Inc. (012578514)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(15127-283)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(15127-283) , PACK(15127-283)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(15127-283)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(15127-283)