Label: DIPHENHYDRAMINE HYDROCHLORIDE - diphenhydramine hydrochloride capsule 

  • NDC Code(s): 0603-3339-21, 0603-3339-32
  • Packager: Qualitest Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

If you are a consumer or patient please visit this version.

  • Drug Facts

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  • Active Ingredient

    (in each capsule)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Antihistamine

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  • Uses

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

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

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  • Keep out of reach of children.

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

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  • 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
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  • 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
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  • 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

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  • 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.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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    DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG

    ANTIHISTAMINE

    NDC: 0603-3339-21 – 100 COUNT

    NDC: 0603-3339-32 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)

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  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0603-3339
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL  
    BUTYLPARABEN  
    D&C RED NO. 28  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    LACTOSE  
    MAGNESIUM STEARATE  
    METHYLPARABEN  
    POLYSORBATE 80  
    PROPYLPARABEN  
    SODIUM LAURYL SULFATE  
    Product Characteristics
    Color PINK Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code AP;020
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-3339-21 100 in 1 BOTTLE
    2 NDC:0603-3339-32 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 05/24/2007
    Labeler - Qualitest Pharmaceuticals (011103059)
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