Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • 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 January 20, 2020

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  • DRUG FACTS

    .

  • ACTIVE INGREDIENT

    (in each capsule)

    Diphenhydramine HCl 25 mg

  • PURPOSE

    Antihistamine

  • INDICATIONS & USAGE

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

    runny nose
    itchy nose or throat
    sneezing
    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 tranquilizers

    When using this product

    you may get very drowsy
    avoid alcoholic drinks
    alcohol, sedatives & 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 REACH OF CHILDREN.

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

  • DIRECTIONS

    adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
    children under 12 years: ask a doctor

  • OTHER INFORMATION

    store at 15-30 °C (59-86 °F)
    protect from moisture
    For 1000 Count: 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 bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate

  • QUESTIONS OR COMMENTS

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

    Distributed by: Qualitest Pharmaceuticals, Inc.

  • DOSAGE & ADMINISTRATION

    adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
    children under 12 years: ask a doctor

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    diph

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1055(NDC:0603-3339)
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code AP;020
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67296-1055-124 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2018
    Labeler - RedPharm Drug, Inc. (828374897)
    Establishment
    NameAddressID/FEIBusiness Operations
    RedPharm Drug, Inc.828374897repack(67296-1055) , relabel(67296-1055)
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