Label: ADVIL- ibuprofen capsule, liquid filled 

  • NDC Code(s): 0573-0169-02, 0573-0169-08, 0573-0169-11, 0573-0169-13, view more
    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, 0573-0169-86, 0573-0169-89
  • Packager: Pfizer Consumer Healthcare
  • 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 09/14

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

    FD&C green no. 3, gelatin, light mineral oil, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

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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 LABEL Item Code (Source) NDC:0573-0169
    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
    FD&C GREEN NO. 3  
    GELATIN  
    LIGHT MINERAL OIL  
    POLYETHYLENE GLYCOLS  
    POTASSIUM HYDROXIDE  
    SORBITAN  
    SORBITOL  
    WATER  
    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; Combination Product Type = C112160
    2 NDC:0573-0169-02 50 in 1 BOX
    2 2 in 1 POUCH; Combination Product Type = C112160
    3 NDC:0573-0169-19 1 in 1 CARTON
    3 4 in 1 BLISTER PACK; Combination Product Type = C112160
    4 NDC:0573-0169-20 1 in 1 CARTON
    4 20 in 1 BOTTLE; Combination Product Type = C112160
    5 NDC:0573-0169-40 1 in 1 CARTON
    5 80 in 1 BOTTLE; Combination Product Type = C112160
    6 NDC:0573-0169-11 1 in 1 CARTON
    6 120 in 1 BOTTLE; Combination Product Type = C112160
    7 NDC:0573-0169-89 1 in 1 CARTON
    7 160 in 1 BOTTLE; Combination Product Type = C112160
    8 NDC:0573-0169-30 1 in 1 CARTON
    8 40 in 1 BOTTLE; Combination Product Type = C112160
    9 NDC:0573-0169-31 1 in 1 CARTON
    9 60 in 1 BOTTLE; Combination Product Type = C112160
    10 NDC:0573-0169-86 1 in 1 CARTON
    10 100 in 1 BOTTLE; Combination Product Type = C112160
    11 NDC:0573-0169-51 1 in 1 CARTON
    11 180 in 1 BOTTLE; Combination Product Type = C112160
    12 NDC:0573-0169-43 1 in 1 CARTON
    12 120 in 1 BOTTLE; Combination Product Type = C112160
    13 NDC:0573-0169-49 200 in 1 BOTTLE; Combination Product Type = C112160
    14 NDC:0573-0169-52 1 in 1 CARTON
    14 200 in 1 BOTTLE; Combination Product Type = C112160
    15 NDC:0573-0169-08 2 in 1 CARTON
    15 120 in 1 BOTTLE; Combination Product Type = C112160
    16 NDC:0573-0169-22 1 in 1 CARTON
    16 30 in 1 BOTTLE; Combination Product Type = C112160
    17 NDC:0573-0169-13 240 in 1 BOTTLE; Combination Product Type = C112160
    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, Consumer Site 829390975 ANALYSIS(0573-0169), LABEL(0573-0169), MANUFACTURE(0573-0169), PACK(0573-0169)
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