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, 0573-1769-02, 0573-1769-09, 0573-1769-13, 0573-1769-14, 0573-1769-20, 0573-1769-80, 0573-1769-89
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 3, 2024

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  • 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 at 20 weeks or later in 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

    Advil®
    LIQUI•GELS®

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

    20
    Liquid Filled
    Capsules

    000068421 Front Carton

    Advil Liquigels 200 mg 20 Capsules
  • PRINCIPAL DISPLAY PANEL- 160 Capsule Bottle Label

     
    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

    Advil Liquigels 200 mg 160 Capsules
  • PRINCIPAL DISPLAY PANEL

    Smaller
    Capsule

    Same
    Strength*

    Advil®
    LIQUI•GELS®

    minis

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

    20
    Liquid Filled
    Capsules

    000068424 Front Carton

    Advil Liquigels Minis 200 mg 20 Capsules
  • 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)  
    SOYBEAN LECITHIN (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)  
    SOYBEAN LECITHIN (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
    7NDC:0573-1769-0250 in 1 CARTON06/01/2018
    72 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02040203/08/2017
    Labeler - Haleon US Holdings LLC (079944263)
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