Label: DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule

  • 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 11/14

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

    Diphenhydramine HCl 50 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

    Diphenhydramine 25mg

    Bottle of 10 - 68788-9697-1

    Bottle of 30 - 68788-9697-3

    Diphenhydramine 50mg

    Bottle of 30 - 68788-9698-3

    store at 15-30 °C (59-86 °F)
    protect from moisture
    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 blue #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

    DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG

    ANTIHISTAMINE

    Diphenhydramine HCl Capsules, USP 25mg
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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 50 MG

    ANTIHISTAMINE

    Diphenhydramine HCl Capsules, USP 50mg
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  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68788-9697(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:68788-9697-1 10 in 1 BOTTLE; Combination Product Type = C112160
    2 NDC:68788-9697-3 30 in 1 BOTTLE; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/19/2013
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68788-9698(NDC:0603-3340)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 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;021
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-9698-3 30 in 1 BOTTLE; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/19/2013
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals, Inc. 791119022 REPACK(68788-9697, 68788-9698)
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