Label: ADVIL- ibuprofen capsule, liquid filled

  • NDC Code(s): 0573-0149-04, 0573-0149-13, 0573-0149-66, 0573-0149-91, view more
    0573-0169-02, 0573-0169-08, 0573-0169-11, 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, 0573-1769-09, 0573-1769-13, 0573-1769-14, 0573-1769-20, 0573-1769-80, 0573-1769-89
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 10, 2020

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

  • 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

  • PURPOSE

    Pain reliever/Fever reducer

  • 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
  • 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

    Heart attack and stroke warning

    NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, asthma, or had a stroke
    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

    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
    you have symptoms of heart problems or stroke:
    chest pain
    trouble breathing
    weakness in one part or side of body
    slurred speech
    leg swelling
    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.

  • 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
  • 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)
  • INACTIVE INGREDIENTS

    Advil Liqui-Gels

    FD&C green no. 3, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

    Advil Liqui-Gels Minis

    FD&C green no. 3, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

  • QUESTIONS OR COMMENTS?

    call toll free 1-800-88-ADVIL

  • PRINCIPAL DISPLAY PANEL - 40 Capsule Bottle Carton

    0573-0169-30

    Advil®
    LIQUI•GELS®

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

    40
    Liquid Filled
    Capsules

    PRINCIPAL DISPLAY PANEL - 40 Capsule Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 160 Capsule Bottle Label

     
    0573-0149-66

    Easy Open
    ARTHRITIS CAP

    Arthritis Foundation
    Ease of
    Use℠
    CAP

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    Advil®
    LIQUI•GELS®

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

    160
    Liquid Filled
    Capsules

    PRINCIPAL DISPLAY PANEL - 160 Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Carton

    0573-1769-20

    Smaller
    Capsule

    Same
    Strength*

    Advil®
    LIQUI•GELS®

    minis

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

    20
    Liquid Filled
    Capsules

    *Compared to Advil® Liqui-Gels®

    PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ADVIL 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0169
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorGREEN (Transparent green to blue green) Scoreno score
    ShapeCAPSULE (oblong softgel) Size20mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0169-173000 in 1 CASE04/10/1995
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0573-0169-0250 in 1 BOX04/10/1995
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0573-0169-191 in 1 CARTON04/10/1995
    34 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0573-0169-201 in 1 CARTON04/10/1995
    420 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0573-0169-401 in 1 CARTON04/10/1995
    580 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0573-0169-111 in 1 CARTON04/10/1995
    6120 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0573-0169-891 in 1 CARTON04/10/1995
    7160 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0573-0169-301 in 1 CARTON04/10/1995
    840 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0573-0169-311 in 1 CARTON04/10/1995
    960 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:0573-0169-861 in 1 CARTON04/10/1995
    10100 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:0573-0169-511 in 1 CARTON04/10/1995
    11180 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:0573-0169-431 in 1 CARTON04/10/1995
    12120 in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:0573-0169-49200 in 1 BOTTLE; Type 0: Not a Combination Product04/10/1995
    14NDC:0573-0169-521 in 1 CARTON04/10/1995
    14200 in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:0573-0169-082 in 1 CARTON04/10/1995
    15120 in 1 BOTTLE; Type 0: Not a Combination Product
    16NDC:0573-0169-221 in 1 CARTON04/10/1995
    1630 in 1 BOTTLE; Type 0: Not a Combination Product
    17NDC:0573-0169-13240 in 1 BOTTLE; Type 0: Not a Combination Product04/10/1995
    18NDC:0573-0169-761 in 1 CARTON04/10/1995
    18160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02040204/10/1995
    ADVIL 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0149
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorGREEN (Transparent green to blue green) Scoreno score
    ShapeCAPSULE (oblong softgel) Size20mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0149-131 in 1 CARTON04/10/1995
    180 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0149-042 in 1 BLISTER PACK03/01/2018
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0573-0149-66160 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2016
    4NDC:0573-0149-91180 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02040204/10/1995
    ADVIL 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1769
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorGREEN (transparent green to blue green) Scoreno score
    ShapeCAPSULE (oblong softgel) Size13mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-1769-201 in 1 CARTON03/08/2017
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-1769-801 in 1 CARTON03/08/2017
    280 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0573-1769-891 in 1 CARTON03/08/2017
    3160 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0573-1769-14240 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
    5NDC:0573-1769-13200 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
    6NDC:0573-1769-091 in 1 BLISTER PACK06/01/2018
    68 in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02040203/08/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0149, 0573-0169, 0573-1769) , LABEL(0573-0149, 0573-0169, 0573-1769) , MANUFACTURE(0573-0149, 0573-0169, 0573-1769) , PACK(0573-0149, 0573-0169, 0573-1769)