Label: ADVIL- ibuprofen tablet, coated 

  • Label RSS
  • 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, 0573-0151-10, 0573-0151-12, 0573-0151-13, 0573-0151-21, 0573-0154-17, 0573-0154-35, 0573-0154-75, 0573-0154-84, 0573-0154-89, 0573-0154-98, 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, 0573-0161-85, 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
  • 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 06/14

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

  • DRUG FACTS
  • 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

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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 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

    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

    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
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  • 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)
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  • 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

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  • PRINCIPAL DISPLAY PANEL - 100 Count 200 mg Gel Caplet 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 - 50 Count 200 mg Gel Caplet Carton
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  • 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
    Close
  • PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

    Advil®

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

    Tablets

    Headache
    Minor Pain of Arthritis
    Toothache
    Muscular Aches
    Menstrual Cramps
    Fever

    50 PACKETS OF 2 COATED TABLETS EACH

    Principal Display Panel - 50 Pouch Carton
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  • PRINCIPAL DISPLAY PANEL - 10 Count 200 mg Tablet Blister Pack

    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 Count 200 mg Tablet Blister Pack
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  • PRINCIPAL DISPLAY PANEL - 150 Count 200 mg Caplet Carton

    EASE-OF-USE
    CAP
    ARTHRITIS FOUNDATION

    Easy Open
    ARTHRITIS
    CAP!

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    Advil®

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

    150 Coated Caplets*
    *Capsule-Shaped Tablets

    Caplets

    Principal Display Panel - 150 Count 200 mg Caplet Carton
    Close
  • PRINCIPAL DISPLAY PANEL - 200 Count 200 mg Gel Caplet Carton

    Advil®

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

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

    Gel Caplets

    Principal Display Panel - 200 Count 200 mg Gel Caplet Carton
    Close
  • PRINCIPAL DISPLAY PANEL - 100 Count 200 mg Tablet Carton

    Advil®

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

    100 Coated Tablets

    Tablets

    PRINCIPAL DISPLAY PANEL - 100 Count 200 mg Tablet Carton
    Close
  • PRINCIPAL DISPLAY PANEL - 50 Count 200 mg Caplet Carton

    Advil®

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

    50 Coated Caplets*
    *Capsule-Shaped Tablets

    Caplets

    Principal Display Panel - 50 Count 200 mg Caplet Carton
    Close
  • INGREDIENTS AND APPEARANCE
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-0165
    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
    CROSCARMELLOSE SODIUM  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    FERRIC OXIDE RED  
    GELATIN  
    GLYCERIN  
    HYPROMELLOSES  
    MEDIUM-CHAIN TRIGLYCERIDES  
    PROPYL GALLATE  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    STARCH, CORN  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TRIACETIN  
    WATER  
    Product Characteristics
    Color BROWN (one hemisphere is brown while the other hemisphere is yellow) Score no score
    Shape OVAL (smooth in texture with polished surface) Size 16mm
    Flavor Imprint Code Advil
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0165-20 1 in 1 CARTON
    1 24 in 1 BOTTLE
    2 NDC:0573-0165-30 1 in 1 CARTON
    2 50 in 1 BOTTLE
    3 NDC:0573-0165-40 1 in 1 CARTON
    3 100 in 1 BOTTLE
    4 NDC:0573-0165-41 1 in 1 CARTON
    4 125 in 1 BOTTLE
    5 NDC:0573-0165-42 1 in 1 CARTON
    5 150 in 1 BOTTLE
    6 NDC:0573-0165-31 1 in 1 CARTON
    6 75 in 1 BOTTLE
    7 NDC:0573-0165-25 1 in 1 CARTON
    7 36 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018989 05/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-0154
    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
    CELLULOSE, MICROCRYSTALLINE  
    CROSCARMELLOSE SODIUM  
    FERRIC OXIDE RED  
    METHYLPARABEN  
    POVIDONES  
    PROPYLPARABEN  
    SHELLAC  
    SILICON DIOXIDE  
    SODIUM BENZOATE  
    SODIUM LAURYL SULFATE  
    STARCH, CORN  
    STEARIC ACID  
    SUCROSE  
    TITANIUM DIOXIDE  
    WHITE WAX  
    DIACETYLATED MONOGLYCERIDES  
    Product Characteristics
    Color BROWN (pinkish brown) Score no score
    Shape ROUND (smooth in texture with polished surface) Size 10mm
    Flavor Imprint Code Advil
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0154-35 1 in 1 CARTON
    1 150 in 1 BOTTLE
    2 NDC:0573-0154-75 1 in 1 CARTON
    2 200 in 1 BOTTLE
    3 NDC:0573-0154-17 3000 in 1 CASE
    3 2 in 1 POUCH
    4 NDC:0573-0154-89 50 in 1 CASE
    4 2 in 1 POUCH
    5 NDC:0573-0154-84 1 in 1 CARTON
    5 225 in 1 BOTTLE
    6 NDC:0573-0154-98 300 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018989 05/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-0151
    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
    CELLULOSE, MICROCRYSTALLINE  
    CROSCARMELLOSE SODIUM  
    FERRIC OXIDE RED  
    METHYLPARABEN  
    POVIDONES  
    PROPYLPARABEN  
    SHELLAC  
    SILICON DIOXIDE  
    SODIUM BENZOATE  
    SODIUM LAURYL SULFATE  
    STARCH, CORN  
    STEARIC ACID  
    SUCROSE  
    TITANIUM DIOXIDE  
    WHITE WAX  
    DIACETYLATED MONOGLYCERIDES  
    Product Characteristics
    Color BROWN (pinkish brown) Score no score
    Shape ROUND (smooth in texture with polished suface) Size 10mm
    Flavor Imprint Code Advil
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0151-12 10 in 1 VIAL
    2 NDC:0573-0151-13 3 in 1 PACKAGE
    2 10 in 1 VIAL
    3 NDC:0573-0151-10 10 in 1 PACKAGE
    3 10 in 1 VIAL
    4 NDC:0573-0151-21 1 in 1 CARTON
    4 36 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018989 05/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-0161
    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
    CELLULOSE, MICROCRYSTALLINE  
    CROSCARMELLOSE SODIUM  
    FERRIC OXIDE RED  
    METHYLPARABEN  
    POVIDONES  
    PROPYLPARABEN  
    SHELLAC  
    SILICON DIOXIDE  
    SODIUM BENZOATE  
    SODIUM LAURYL SULFATE  
    STARCH, CORN  
    STEARIC ACID  
    SUCROSE  
    TITANIUM DIOXIDE  
    WHITE WAX  
    DIACETYLATED MONOGLYCERIDES  
    Product Characteristics
    Color BROWN (pinkish brown) Score no score
    Shape OVAL (smooth in texture polished oval shaped tablet) Size 15mm
    Flavor Imprint Code Advil
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0161-35 1 in 1 CARTON
    1 150 in 1 BOTTLE
    2 NDC:0573-0161-51 1 in 1 CARTON
    2 200 in 1 BOTTLE
    3 NDC:0573-0161-85 1 in 1 CARTON
    3 225 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018989 05/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-0166
    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
    CROSCARMELLOSE SODIUM  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    FERRIC OXIDE RED  
    GELATIN  
    GLYCERIN  
    HYPROMELLOSES  
    MEDIUM-CHAIN TRIGLYCERIDES  
    PROPYL GALLATE  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    STARCH, CORN  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TRIACETIN  
    WATER  
    Product Characteristics
    Color BROWN (one hemisphere is brown while the other hemisphere is yellow) Score no score
    Shape OVAL (smooth in texture with polished surface) Size 16mm
    Flavor Imprint Code Advil
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0166-51 1 in 1 CARTON
    1 200 in 1 BOTTLE
    2 NDC:0573-0166-85 225 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018989 05/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-0150
    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
    CELLULOSE, MICROCRYSTALLINE  
    CROSCARMELLOSE SODIUM  
    FERRIC OXIDE RED  
    METHYLPARABEN  
    POVIDONES  
    PROPYLPARABEN  
    SHELLAC  
    SILICON DIOXIDE  
    SODIUM BENZOATE  
    SODIUM LAURYL SULFATE  
    STARCH, CORN  
    STEARIC ACID  
    SUCROSE  
    TITANIUM DIOXIDE  
    WHITE WAX  
    DIACETYLATED MONOGLYCERIDES  
    Product Characteristics
    Color BROWN (pinkish brown) Score no score
    Shape ROUND (smooth in texture with polish surface) Size 10mm
    Flavor Imprint Code Advil
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0150-20 1 in 1 CARTON
    1 24 in 1 BOTTLE
    2 NDC:0573-0150-30 1 in 1 CARTON
    2 50 in 1 BOTTLE
    3 NDC:0573-0150-40 1 in 1 CARTON
    3 100 in 1 BOTTLE
    4 NDC:0573-0150-31 1 in 1 CARTON
    4 75 in 1 BOTTLE
    5 NDC:0573-0150-32 1 in 1 CARTON
    5 60 in 1 BOTTLE
    6 NDC:0573-0150-41 1 in 1 CARTON
    6 125 in 1 BOTTLE
    7 NDC:0573-0150-42 1 in 1 CARTON
    7 150 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018989 05/18/1984
    ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-0160
    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
    CELLULOSE, MICROCRYSTALLINE  
    CROSCARMELLOSE SODIUM  
    FERRIC OXIDE RED  
    METHYLPARABEN  
    POVIDONES  
    PROPYLPARABEN  
    SHELLAC  
    SILICON DIOXIDE  
    SODIUM BENZOATE  
    SODIUM LAURYL SULFATE  
    STARCH, CORN  
    STEARIC ACID  
    SUCROSE  
    TITANIUM DIOXIDE  
    WHITE WAX  
    DIACETYLATED MONOGLYCERIDES  
    Product Characteristics
    Color BROWN (pinkish brown) Score no score
    Shape OVAL (smooth in texture polished oval shaped tablet) Size 15mm
    Flavor Imprint Code Advil
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0160-20 1 in 1 CARTON
    1 24 in 1 BOTTLE
    2 NDC:0573-0160-30 1 in 1 CARTON
    2 50 in 1 BOTTLE
    3 NDC:0573-0160-40 1 in 1 CARTON
    3 100 in 1 BOTTLE
    4 NDC:0573-0160-25 1 in 1 CARTON
    4 36 in 1 BOTTLE
    5 NDC:0573-0160-31 1 in 1 CARTON
    5 75 in 1 BOTTLE
    6 NDC:0573-0160-41 1 in 1 CARTON
    6 125 in 1 BOTTLE
    7 NDC:0573-0160-42 1 in 1 CARTON
    7 150 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018989 05/18/1984
    Labeler - Pfizer Consumer Healthcare (828831730)
    Establishment
    Name Address ID/FEI Business Operations
    Wyeth Pharmaceuticals Company, Consumer Site 829390975 ANALYSIS(0573-0165, 0573-0160, 0573-0150, 0573-0166, 0573-0161, 0573-0151, 0573-0154), LABEL(0573-0165, 0573-0160, 0573-0150, 0573-0166, 0573-0161, 0573-0151, 0573-0154), MANUFACTURE(0573-0165, 0573-0160, 0573-0150, 0573-0166, 0573-0161, 0573-0151, 0573-0154), PACK(0573-0165, 0573-0160, 0573-0150, 0573-0166, 0573-0161, 0573-0151, 0573-0154)
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