Label: ADVIL- ibuprofen tablet, coated

  • NDC Code(s): 0573-0150-20, 0573-0150-30, 0573-0150-31, 0573-0150-32, view more
    0573-0150-40, 0573-0150-41, 0573-0150-42, 0573-0151-05, 0573-0151-10, 0573-0151-12, 0573-0151-13, 0573-0151-20, 0573-0151-21, 0573-0151-30, 0573-0151-48, 0573-0154-16, 0573-0154-17, 0573-0154-21, 0573-0154-35, 0573-0154-59, 0573-0154-60, 0573-0154-75, 0573-0154-84, 0573-0154-89, 0573-0154-98, 0573-0160-17, 0573-0160-20, 0573-0160-25, 0573-0160-30, 0573-0160-31, 0573-0160-40, 0573-0160-41, 0573-0160-42, 0573-0161-35, 0573-0161-51, 0573-0161-65, 0573-0161-85, 0573-0165-20, 0573-0165-25, 0573-0165-30, 0573-0165-31, 0573-0165-40, 0573-0165-41, 0573-0165-42, 0573-0166-51, 0573-0166-85, 0573-1711-14
  • 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 13, 2020

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

  • ACTIVE INGREDIENT

    Advil Tablets (in each tablet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Advil Caplets (in each caplet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Advil Gel Caplets (in each gel caplet)

    Ibuprofen 200 mg (NSAID)*

    *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 non-prescription 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

    Advil Tablets

    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

    Advil Caplets

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

    Advil Gel Caplets

    do not take more than directed
    the smallest effective dose should be used
    adults and children 12 years and over: take 1 gel caplet every 4 to 6 hours while symptoms persist
    if pain or fever does not respond to 1 gel caplet, 2 gel caplets may be used
    do not exceed 6 gel caplets in 24 hours, unless directed by a doctor
    children under 12 years: ask a doctor
  • 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)
  • INACTIVE INGREDIENTS

    Advil Tablets

    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

    Advil Caplets

    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

    Advil Gel Caplets

    colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40, FD&C yellow no. 6, fractionated coconut oil, gelatin, glycerin, hypromellose, pharmaceutical ink, pregelatinized starch, propyl gallate, purified water, sodium lauryl sulfate, stearic acid, synthetic iron oxides, titanium dioxide, triacetin

    Questions or comments?

    call toll free 1-800-88-ADVIL

  • PRINCIPAL DISPLAY PANEL - 200 mg Gel Caplet Bottle Label

    Advil®

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

    100 Gel Caplets
    Gel Caplets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    Do Not Use if seal under bottle cap imprinted with
    "SEALED for YOUR PROTECTION" is broken or missing.

    PRINCIPAL DISPLAY PANEL - 200 mg Gel Caplet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 100 Count 200 mg Gel Caplet Bottle Carton

    Advil®

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

    100 Coated Gel Caplets*
    *Capsule-Shaped Gelatin-Coated Tablets

    Gel
    Caplets

    PRINCIPAL DISPLAY PANEL - 100 Count 200 mg Gel Caplet Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 2 Count 200 mg Tablet Pouch

    Advil®

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

    2 Coated Tablets

    PRINCIPAL DISPLAY PANEL - 2 Count 200 mg Tablet Pouch
  • PRINCIPAL DISPLAY PANEL - 50 Pouch Dispenser

    Advil®

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

    Tablets

    1.
    Headache
    2.
    Minor Pain of Arthritis
    3.
    Toothache
    4.
    Muscular Aches
    5.
    Menstrual Cramps
    6.
    Fever

    50 PACKETS OF 2 COATED TABLETS EACH

    Principal Display Panel - 50 Pouch Dispenser
  • PRINCIPAL DISPLAY PANEL - 300 Tablet Bottle Label - NDC 0573-0154-98

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

    300 Coated Tablets

    Tablets

    Principal Display Panel - 300 Tablet Bottle Label - NDC 0573-0154-98
  • PRINCIPAL DISPLAY PANEL - 200 Count 200 mg Tablet Bottle Label

    New Easy Open
    ARTHRITIS CAP

    Arthritis Foundation
    Ease of
    UseSM
    CAP

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    Advil®

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

    200 Coated Tablets

    Tablets

    PRINCIPAL DISPLAY PANEL - 200 Count 200 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 10 Tablet Vial Label

    Advil®

    Tablets

    Ibuprofen Tablets, 200 mg
    Pain Reliever/Fever Reducer (NSAID)
    10 Coated Tablets

    PRINCIPAL DISPLAY PANEL - 10 Tablet Vial Label
  • PRINCIPAL DISPLAY PANEL - 200 mg Tablet Vial Label

    Advil ®

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

    10 Tablets

    Tablets

    PRINCIPAL DISPLAY PANEL - 200 mg Tablet Vial Label
  • PRINCIPAL DISPLAY PANEL - 10 Tablet Package

    Pocket
    Pack

    Do not use if blister is open or the
    words "ADVIL SAFETY SEALED"
    under blister are missing or torn.

    Advil®

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

    10 Coated Tablets

    Tablets

    Principal Display Panel - 10 Tablet Package
  • PRINCIPAL DISPLAY PANEL - 115 Tablet Bottle Label

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

    115 Tablets

    Tablets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    Do Not Use if seal under bottle cap imprinted with
    "SEALED for YOUR PROTECTION" is broken or missing.

    Principal Display Panel - 115 Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 115 Tablet Bottle Carton - NDC 0573-0151-05

    15
    FREE
    TABLETS

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

    115
    Coated Tablets

    Tablets

    Principal Display Panel - 115 Tablet Bottle Carton - NDC 0573-0151-05
  • PRINCIPAL DISPLAY PANEL - 225 Caplet Bottle Label

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

    225 Caplets

    Caplets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    Principal Display Panel - 225 Caplet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 225 Caplet Bottle Carton - NDC 0573-0161-85

    25
    FREE
    CAPLETS

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

    225
    Coated Caplets*
    *Capsule-Shaped Tablets

    Caplets

    Principal Display Panel - 225 Caplet Bottle Carton - NDC 0573-0161-85
  • PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Label

    Advil®

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

    24 Tablets

    Tablets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    Principal Display Panel - 24 Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton - NDC 0573-0150-20

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

    24 Coated Tablets

    Tablets

    Principal Display Panel - 24 Tablet Bottle Carton - NDC 0573-0150-20
  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    Advil®

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

    100 Tablets
    Tablets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    Do Not Use if seal under bottle cap imprinted with
    "SEALED for YOUR PROTECTION" is broken or missing.

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 100 Count 200 mg Tablet Bottle Carton

    Advil®

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

    100 Coated Tablets

    Tablets

    PRINCIPAL DISPLAY PANEL - 100 Count 200 mg Tablet Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

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

    100 Tablets

    Tablets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    Do Not Use if seal under bottle cap imprinted with
    "SEALED for YOUR PROTECTION" is broken or missing.

    Principal Display Panel - 100 Tablet Bottle Label - 100
  • PRINCIPAL DISPLAY PANEL - 100 Coated Tablet Bottle Carton - NDC 0573-0150-40

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

    100 Coated Tablets

    Tablets

    Principal Display Panel - 100 Coated Tablet Bottle Carton - NDC 0573-0150-40
  • PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Label

    Advil®

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

    24 Caplets

    Caplets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    Principal Display Panel - 24 Caplet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton - NDC 0573-0160-20

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

    24 Coated Caplets*
    *Capsule-Shaped Tablets

    Caplets

    Principal Display Panel - 24 Caplet Bottle Carton - NDC 0573-0160-20
  • PRINCIPAL DISPLAY PANEL - 200 mg Caplet Bottle Label

    Advil®

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

    100 Caplets
    Caplets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    Do Not Use if seal under bottle cap imprinted with
    "SEALED for YOUR PROTECTION" is broken or missing.

    PRINCIPAL DISPLAY PANEL - 200 mg Caplet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 100 Count 200 mg Caplet Bottle Carton

    Advil®

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

    50 Coated Caplets*
    *Capsule-Shaped Tablets

    Caplets

    Principal Display Panel - 100 Count 200 mg Caplet Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 36 Caplet Bottle Label

    Advil®

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

    36 Caplets

    Caplets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    Principal Display Panel - 36 Caplet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 36 Caplet Bottle Carton - NDC 0573-0160-25

    50%
    MORE
    FREE

    12 Free
    Caplets

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

    36
    Coated Caplets*
    *Capsule-Shaped Tablets

    Caplets

    Principal Display Panel - 36 Caplet Bottle Carton - NDC 0573-0160-25
  • INGREDIENTS AND APPEARANCE
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0165
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBROWN (one side is brown while the other side is yellow) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0165-201 in 1 CARTON05/18/1984
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0165-301 in 1 CARTON05/18/1984
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0573-0165-401 in 1 CARTON05/18/1984
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0573-0165-411 in 1 CARTON05/18/1984
    4125 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0573-0165-421 in 1 CARTON05/18/1984
    5150 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0573-0165-311 in 1 CARTON05/18/1984
    675 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0573-0165-251 in 1 CARTON05/18/1984
    736 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0154
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    Product Characteristics
    ColorBROWN (pinkish brown) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0154-351 in 1 CARTON05/18/1984
    1150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0154-751 in 1 CARTON05/18/1984
    2200 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0573-0154-173000 in 1 CASE05/18/1984
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0573-0154-8950 in 1 CASE05/18/1984
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0573-0154-841 in 1 CARTON05/18/1984
    5225 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0573-0154-98300 in 1 BOTTLE; Type 0: Not a Combination Product05/18/1984
    7NDC:0573-0154-163 in 1 CARTON05/18/1984
    72 in 1 POUCH; Type 0: Not a Combination Product
    8NDC:0573-0154-60360 in 1 BOTTLE; Type 0: Not a Combination Product05/18/1984
    9NDC:0573-0154-591 in 1 CARTON05/18/1984
    9200 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:0573-0154-21200 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0151
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    Product Characteristics
    ColorBROWN (pinkish brown) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0151-1210 in 1 VIAL; Type 0: Not a Combination Product05/18/1984
    2NDC:0573-0151-133 in 1 PACKAGE05/18/1984
    210 in 1 VIAL; Type 0: Not a Combination Product
    3NDC:0573-0151-1010 in 1 PACKAGE05/18/1984
    310 in 1 VIAL; Type 0: Not a Combination Product
    4NDC:0573-0151-211 in 1 CARTON05/18/1984
    436 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0573-0151-202 in 1 PACKAGE05/18/1984
    510 in 1 VIAL; Type 0: Not a Combination Product
    6NDC:0573-0151-482 in 1 PACKAGE05/18/1984
    61 in 1 CARTON
    6100 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0573-0151-301 in 1 CARTON05/18/1984
    7130 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0573-0151-051 in 1 CARTON05/18/1984
    8115 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    Product Characteristics
    ColorBROWN (pinkish brown) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0161-351 in 1 CARTON05/18/1984
    1150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0161-511 in 1 CARTON05/18/1984
    2200 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0573-0161-851 in 1 CARTON05/18/1984
    3225 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0573-0161-6565 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0166
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBROWN (one side is brown while the other side is yellow) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0166-511 in 1 CARTON05/18/1984
    1200 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0166-85225 in 1 BOTTLE; Type 0: Not a Combination Product05/18/1984
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0150
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    Product Characteristics
    ColorBROWN (pinkish brown) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0150-201 in 1 CARTON05/18/1984
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0150-301 in 1 CARTON05/18/1984
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0573-0150-401 in 1 CARTON05/18/1984
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0573-0150-311 in 1 CARTON05/18/1984
    475 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0573-0150-321 in 1 CARTON05/18/1984
    560 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0573-0150-411 in 1 CARTON05/18/1984
    6125 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0573-0150-421 in 1 CARTON05/18/1984
    7150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    Product Characteristics
    ColorBROWN (pinkish brown) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0160-201 in 1 CARTON05/18/1984
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0160-301 in 1 CARTON05/18/1984
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0573-0160-401 in 1 CARTON05/18/1984
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0573-0160-251 in 1 CARTON05/18/1984
    436 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0573-0160-311 in 1 CARTON05/18/1984
    575 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0573-0160-411 in 1 CARTON05/18/1984
    6125 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0573-0160-421 in 1 CARTON05/18/1984
    7150 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0573-0160-171 in 1 CARTON05/18/1984
    8115 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1711
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    Product Characteristics
    ColorBROWN (pinkish brown) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code Advil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-1711-141 in 1 CARTON05/18/1984
    1225 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01898905/18/1984
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711) , LABEL(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711) , MANUFACTURE(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711) , PACK(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711)