Label: ADVIL- ibuprofen 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Ibuprofen 200 mg (NSAID)1


    1
    nonsteroidal anti-inflammatory drug
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  • Purpose

    Pain reliever/Fever reducer

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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • toothache
      • backache
      • menstrual cramps
      • the common cold
      • muscular aches
      • minor pain of arthritis
    • temporarily reduces fever
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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
    • right before or after heart surgery

    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

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • taking any other drug

    When using this product

    • 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
    • fever gets worse or lasts more than 3 days
    • 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
    • the smallest effective dose should be used
    • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor
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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

    acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

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  • Questions or comments?

    call toll free 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 - 200 mg Tablet Carton

    Advil®
    Ibuprofen Tablets, 200 mg
    Pain Reliever / Fever Reducer (NSAID)

    Tablets

    4
    COATED
    TABLETS

    Lil'
    Drug Store®

    Principal Display Panel - 4 tablet carton
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  • INGREDIENTS AND APPEARANCE
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66715-9700(NDC:0573-0154)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ibuprofen (Ibuprofen) Ibuprofen 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    diacetylated monoglycerides  
    silicon dioxide  
    starch, corn  
    croscarmellose sodium  
    methylparaben  
    cellulose, microcrystalline  
    shellac  
    povidones  
    propylparaben  
    sodium benzoate  
    sodium lauryl sulfate  
    stearic acid  
    sucrose  
    titanium dioxide  
    white wax  
    Product Characteristics
    Color BROWN (pinkish brown) Score no score
    Shape ROUND (Smooth in texture w/ polish surface) Size 10mm
    Flavor Imprint Code Advil
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66715-9700-1 1 in 1 CARTON
    1 2 in 1 POUCH
    2 NDC:66715-9700-2 2 in 1 CARTON
    2 2 in 1 POUCH
    3 NDC:66715-9700-3 3 in 1 CARTON
    3 2 in 1 POUCH
    4 NDC:66715-9700-8 6 in 1 CARTON
    4 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018989 02/22/2010
    Labeler - Lil' Drug Store Products, Inc. (093103646)
    Establishment
    Name Address ID/FEI Business Operations
    CCB Packaging Inc. 362374464 REPACK(66715-9700), RELABEL(66715-9700)
    Establishment
    Name Address ID/FEI Business Operations
    Pfizer Consumer Healthcare 828831730 LABEL(66715-9700)
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