Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • Category: HUMAN OTC DRUG LABEL

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 November 22, 2016

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  • ACTIVE INGREDIENT (IN EACH CAPSULE)

    Diphenhydramine HCl 25 mg

  • PURPOSE

    Antihistamine

  • USES

    temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes
  • WARNINGS

    ​Do not use​ with any other product containing diphenhydramine, even one used on skin

    ​Ask a doctor before use if you have

    • ​glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    ​Ask a doctor or pharmacist before use if you are​ taking sedatives or tranqulizers

    ​When using this product

    • ​you may get very drowsy
    • 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 or breast-feeding​, ask a health professional before use.

    ​

  • KEEP OUT OF THE REACH OF CHILDREN.

    In case of overdose, get medical help or contact a Poison Control Venter right away.

  • DIRECTIONS

    • adults & children 12 years and over: take 1-2 capsules every 4-6 hours; not more than 6 does in 24 hours
    • ​children under 12 years: ask a doctor
  • OTHER INFORMATION

    • store at 15°-30°C (59°-86°F)
    • protect from moisture
    • This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP
  • INACTIVE INGREDIENTS

    benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

  • QUESTIONS OR COMMENTS?

    call ​888-374-279​ 1, 8:30 am - 4:30 pm ET, Monday - Friday

    ​TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFTEY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

    ​Distributed by:

    Epic Pharma, LLC

    Laurelton, NY

    11413

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 25 MG

    ​Diphenhydramine HCl Capsules, USP​ ​25 mg

    ​ANTIHISTAMINE

    ​1000 Capsules

    ​THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    diphenhydramine-25mg-1000s

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42806-648
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorpinkScoreno score
    ShapecapsuleSize14mm
    FlavorImprint Code AP;020
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42806-648-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/22/2016
    Labeler - Epic Pharma, LLC (827915443)
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