Label: ADVIL PM- ibuprofen and diphenhydramine citrate tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 12/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredient (in each caplet) Purposes
    *
    nonsteroidal anti-inflammatory drug
    Diphenhydramine citrate 38 mg Nighttime sleep-aid
    Ibuprofen 200 mg (NSAID)* Pain reliever
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  • Uses

    • for relief of occasional sleeplessness when associated with minor aches and pains
    • helps you fall asleep and stay asleep
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  • Warnings

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • skin reddening
    • rash
    • blisters

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • unless you have time for a full night's sleep
    • in children under 12 years of age
    • right before or after heart surgery
    • with any other product containing diphenhydramine, even one used on skin
    • if you have sleeplessness without pain

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
    • you are taking a diuretic
    • you have a breathing problem such as emphysema or chronic bronchitis
    • you have glaucoma
    • you have trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers, or any other sleep-aid
    • under a doctor's care for any continuing medical illness
    • taking any other antihistamines
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • taking any other drug

    When using this product

    • drowsiness will occur
    • avoid alcoholic drinks
    • do not drive a motor vehicle or operate machinery
    • take with food or milk if stomach upset occurs
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
    • redness or swelling is present in the painful area
    • any new symptoms appear

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    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

    • do not take more than directed
    • adults and children 12 years and over: take 2 caplets at bedtime
    • do not take more than 2 caplets in 24 hours
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  • Other information

    • read all warnings and directions before use. Keep carton.
    • store at 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F)
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  • Inactive ingredients

    calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

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  • Questions or comments?

    Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

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  • SPL UNCLASSIFIED SECTION

    Repackaged and distributed with permission of Pfizer Consumer Healthcare by:
    Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

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  • PRINCIPAL DISPLAY PANEL - 4 COATED CAPLETS Carton

    Advil® PM

    Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
    Pain Reliever (NSAID) / Nighttime Sleep Aid

    Caplets

    4
    COATED
    CAPLETS*

    *Capsule-Shaped Tablets

    Lil'
    Drug Store®

    PRINCIPAL DISPLAY PANEL - 4 COATED CAPLETS Carton
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  • INGREDIENTS AND APPEARANCE
    ADVIL PM 
    ibuprofen and diphenhydramine citrate tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9733(NDC:0573-0164)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 200 mg
    Diphenhydramine citrate (UNII: 4OD433S209) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine citrate 38 mg
    Inactive Ingredients
    Ingredient Name Strength
    calcium stearate (UNII: 776XM7047L)  
    carnauba wax (UNII: R12CBM0EIZ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    starch, corn (UNII: O8232NY3SJ)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    FD&C blue no. 2 (UNII: L06K8R7DQK)  
    aluminum oxide (UNII: LMI26O6933)  
    glyceryl dibehenate (UNII: R8WTH25YS2)  
    hypromelloses (UNII: 3NXW29V3WO)  
    lactose monohydrate (UNII: EWQ57Q8I5X)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    polydextrose (UNII: VH2XOU12IE)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    stearic acid (UNII: 4ELV7Z65AP)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL (Capsule-Shaped, Smooth in texture w/ polish surface) Size 15mm
    Flavor Imprint Code Advil;PM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66715-9733-2 2 in 1 CARTON
    1 2 in 1 POUCH
    2 NDC:66715-9733-8 5 in 1 CARTON
    2 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021394 05/11/2010
    Labeler - Lil' Drug Store Products, Inc. (093103646)
    Establishment
    Name Address ID/FEI Business Operations
    CCB Packaging Inc. 362374464 REPACK(66715-9733) , RELABEL(66715-9733)
    Establishment
    Name Address ID/FEI Business Operations
    Pfizer Consumer Healthcare 828831730 LABEL(66715-9733)
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