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

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

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 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 LABEL 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 (Ibuprofen) Ibuprofen 200 mg
    Diphenhydramine citrate (Diphenhydramine) Diphenhydramine citrate 38 mg
    Inactive Ingredients
    Ingredient Name Strength
    calcium stearate  
    carnauba wax  
    silicon dioxide  
    starch, corn  
    croscarmellose sodium  
    FD&C blue no. 2  
    aluminum oxide  
    glyceryl dibehenate  
    hypromelloses  
    lactose monohydrate  
    cellulose, microcrystalline  
    polydextrose  
    polyethylene glycols  
    sodium lauryl sulfate  
    stearic acid  
    titanium dioxide  
    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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