Label: ADVIL- ibuprofen capsule, liquid filled

  • NDC Code(s): 0573-0149-13, 0573-0169-02, 0573-0169-08, 0573-0169-11, view more
    0573-0169-13, 0573-0169-17, 0573-0169-19, 0573-0169-20, 0573-0169-22, 0573-0169-30, 0573-0169-31, 0573-0169-40, 0573-0169-43, 0573-0169-49, 0573-0169-51, 0573-0169-52, 0573-0169-76, 0573-0169-86, 0573-0169-89
  • Packager: Pfizer Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 06/15

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

  • DRUG FACTS
  • ACTIVE INGREDIENT (IN EACH CAPSULE)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)

    *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 capsule every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 capsule, 2 capsules may be used
    • do not exceed 6 capsules in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor
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  • OTHER INFORMATION

    • each capsule contains: potassium 20 mg
    • 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

    coconut oil1, FD&C green no. 3, gelatin, lecithin1, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol


    1
    may contain this ingredient
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  • QUESTIONS OR COMMENTS?

    call toll free 1-800-88-ADVIL

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  • PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Label

    Advil®
    LIQUI-GELS®

    Solubilized Ibuprofen Capsules, 200 mg
    Pain Reliever/Fever Reducer (NSAID)

    80 Liquid Filled
    Capsules

    Liquid Filled
    Capsules

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Label
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  • PRODUCT PACKAGING

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    Advil Liqui-Gels

    Solubilized Ibuprofen Capsules, 200 mg

    Pain Reliever/Fever Reducer (NSAID)

    80 Liqui-Gels* *Liquid Filled Capsules

    Liquid Filled Capsules

    Distributed by: Pfizer

    Madison, NJ 07940 USA ©2011 Pfizer Inc.

    LIQUI-GELS is a trademark or registered trademark of Catalent Pharma Solutions.

    Advil Liqui-Gels Packaging
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  • INGREDIENTS AND APPEARANCE
    ADVIL 
    ibuprofen capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0169
    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
    Inactive Ingredients
    Ingredient Name Strength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN (UNII: 2G86QN327L)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color GREEN (Transparent green to blue green) Score no score
    Shape CAPSULE (oblong softgel) Size 20mm
    Flavor Imprint Code Advil
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0169-17 3000 in 1 CASE
    1 2 in 1 POUCH; Type 0: Not a Combination Product
    2 NDC:0573-0169-02 50 in 1 BOX
    2 2 in 1 POUCH; Type 0: Not a Combination Product
    3 NDC:0573-0169-19 1 in 1 CARTON
    3 4 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:0573-0169-20 1 in 1 CARTON
    4 20 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:0573-0169-40 1 in 1 CARTON
    5 80 in 1 BOTTLE; Type 0: Not a Combination Product
    6 NDC:0573-0169-11 1 in 1 CARTON
    6 120 in 1 BOTTLE; Type 0: Not a Combination Product
    7 NDC:0573-0169-89 1 in 1 CARTON
    7 160 in 1 BOTTLE; Type 0: Not a Combination Product
    8 NDC:0573-0169-30 1 in 1 CARTON
    8 40 in 1 BOTTLE; Type 0: Not a Combination Product
    9 NDC:0573-0169-31 1 in 1 CARTON
    9 60 in 1 BOTTLE; Type 0: Not a Combination Product
    10 NDC:0573-0169-86 1 in 1 CARTON
    10 100 in 1 BOTTLE; Type 0: Not a Combination Product
    11 NDC:0573-0169-51 1 in 1 CARTON
    11 180 in 1 BOTTLE; Type 0: Not a Combination Product
    12 NDC:0573-0169-43 1 in 1 CARTON
    12 120 in 1 BOTTLE; Type 0: Not a Combination Product
    13 NDC:0573-0169-49 200 in 1 BOTTLE; Type 0: Not a Combination Product
    14 NDC:0573-0169-52 1 in 1 CARTON
    14 200 in 1 BOTTLE; Type 0: Not a Combination Product
    15 NDC:0573-0169-08 2 in 1 CARTON
    15 120 in 1 BOTTLE; Type 0: Not a Combination Product
    16 NDC:0573-0169-22 1 in 1 CARTON
    16 30 in 1 BOTTLE; Type 0: Not a Combination Product
    17 NDC:0573-0169-13 240 in 1 BOTTLE; Type 0: Not a Combination Product
    18 NDC:0573-0169-76 1 in 1 CARTON
    18 160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020402 04/10/1995
    ADVIL 
    ibuprofen capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0149
    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
    Inactive Ingredients
    Ingredient Name Strength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN (UNII: 2G86QN327L)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color GREEN (Transparent green to blue green) Score no score
    Shape CAPSULE (oblong softgel) Size 20mm
    Flavor Imprint Code Advil
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0149-13 1 in 1 CARTON
    1 80 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020402 04/10/1995
    Labeler - Pfizer Consumer Healthcare (828831730)
    Establishment
    Name Address ID/FEI Business Operations
    Wyeth Pharmaceuticals Company 829390975 ANALYSIS(0573-0149, 0573-0169) , LABEL(0573-0149, 0573-0169) , MANUFACTURE(0573-0149, 0573-0169) , PACK(0573-0149, 0573-0169)
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