ADVIL- ibuprofen tablet, coated 
Pfizer Consumer Healthcare

----------

ADVIL Caplets
ADVIL Gel Caplets
ADVIL Tablets
(ibuprofen)

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

PURPOSE

Pain reliever/Fever reducer

USES

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.

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

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 - 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

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 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

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

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

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

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

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
ADVIL 
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0165
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (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
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; Type 0: Not a Combination Product
2 NDC:0573-0165-30 1 in 1 CARTON
2 50 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0573-0165-40 1 in 1 CARTON
3 100 in 1 BOTTLE; Type 0: Not a Combination Product
4 NDC:0573-0165-41 1 in 1 CARTON
4 125 in 1 BOTTLE; Type 0: Not a Combination Product
5 NDC:0573-0165-42 1 in 1 CARTON
5 150 in 1 BOTTLE; Type 0: Not a Combination Product
6 NDC:0573-0165-31 1 in 1 CARTON
6 75 in 1 BOTTLE; Type 0: Not a Combination Product
7 NDC:0573-0165-25 1 in 1 CARTON
7 36 in 1 BOTTLE; Type 0: Not a Combination Product
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 Item Code (Source) NDC:0573-0154
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONES (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
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; Type 0: Not a Combination Product
2 NDC:0573-0154-75 1 in 1 CARTON
2 200 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0573-0154-17 3000 in 1 CASE
3 2 in 1 POUCH; Type 0: Not a Combination Product
4 NDC:0573-0154-89 50 in 1 CASE
4 2 in 1 POUCH; Type 0: Not a Combination Product
5 NDC:0573-0154-84 1 in 1 CARTON
5 225 in 1 BOTTLE; Type 0: Not a Combination Product
6 NDC:0573-0154-98 300 in 1 BOTTLE; Type 0: Not a Combination Product
7 NDC:0573-0154-16 3 in 1 CARTON
7 2 in 1 POUCH; Type 0: Not a Combination Product
8 NDC:0573-0154-60 360 in 1 BOTTLE; Type 0: Not a Combination Product
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 Item Code (Source) NDC:0573-0151
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONES (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
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; Type 0: Not a Combination Product
2 NDC:0573-0151-13 3 in 1 PACKAGE
2 10 in 1 VIAL; Type 0: Not a Combination Product
3 NDC:0573-0151-10 10 in 1 PACKAGE
3 10 in 1 VIAL; Type 0: Not a Combination Product
4 NDC:0573-0151-21 1 in 1 CARTON
4 36 in 1 BOTTLE; Type 0: Not a Combination Product
5 NDC:0573-0151-20 2 in 1 PACKAGE
5 10 in 1 VIAL; Type 0: Not a Combination Product
6 NDC:0573-0151-48 2 in 1 PACKAGE
6 1 in 1 CARTON
6 100 in 1 BOTTLE; Type 0: Not a Combination Product
7 NDC:0573-0151-30 1 in 1 CARTON
7 130 in 1 BOTTLE; Type 0: Not a Combination Product
8 NDC:0573-0151-05 1 in 1 CARTON
8 115 in 1 BOTTLE; Type 0: Not a Combination Product
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 Item Code (Source) NDC:0573-0161
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONES (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
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; Type 0: Not a Combination Product
2 NDC:0573-0161-51 1 in 1 CARTON
2 200 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0573-0161-85 1 in 1 CARTON
3 225 in 1 BOTTLE; Type 0: Not a Combination Product
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 Item Code (Source) NDC:0573-0166
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (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
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; Type 0: Not a Combination Product
2 NDC:0573-0166-85 225 in 1 BOTTLE; Type 0: Not a Combination Product
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 Item Code (Source) NDC:0573-0150
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONES (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
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; Type 0: Not a Combination Product
2 NDC:0573-0150-30 1 in 1 CARTON
2 50 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0573-0150-40 1 in 1 CARTON
3 100 in 1 BOTTLE; Type 0: Not a Combination Product
4 NDC:0573-0150-31 1 in 1 CARTON
4 75 in 1 BOTTLE; Type 0: Not a Combination Product
5 NDC:0573-0150-32 1 in 1 CARTON
5 60 in 1 BOTTLE; Type 0: Not a Combination Product
6 NDC:0573-0150-41 1 in 1 CARTON
6 125 in 1 BOTTLE; Type 0: Not a Combination Product
7 NDC:0573-0150-42 1 in 1 CARTON
7 150 in 1 BOTTLE; Type 0: Not a Combination Product
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 Item Code (Source) NDC:0573-0160
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONES (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
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; Type 0: Not a Combination Product
2 NDC:0573-0160-30 1 in 1 CARTON
2 50 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0573-0160-40 1 in 1 CARTON
3 100 in 1 BOTTLE; Type 0: Not a Combination Product
4 NDC:0573-0160-25 1 in 1 CARTON
4 36 in 1 BOTTLE; Type 0: Not a Combination Product
5 NDC:0573-0160-31 1 in 1 CARTON
5 75 in 1 BOTTLE; Type 0: Not a Combination Product
6 NDC:0573-0160-41 1 in 1 CARTON
6 125 in 1 BOTTLE; Type 0: Not a Combination Product
7 NDC:0573-0160-42 1 in 1 CARTON
7 150 in 1 BOTTLE; Type 0: Not a Combination Product
8 NDC:0573-0160-17 1 in 1 CARTON
8 115 in 1 BOTTLE; Type 0: Not a Combination Product
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(0573-0160, 0573-0150, 0573-0166, 0573-0161, 0573-0151, 0573-0154, 0573-0165) , LABEL(0573-0160, 0573-0150, 0573-0166, 0573-0161, 0573-0151, 0573-0154, 0573-0165) , MANUFACTURE(0573-0160, 0573-0150, 0573-0166, 0573-0161, 0573-0151, 0573-0154, 0573-0165) , PACK(0573-0160, 0573-0150, 0573-0166, 0573-0161, 0573-0151, 0573-0154, 0573-0165)

Revised: 12/2014
Document Id: d4bb8e69-0fd4-4f64-8bbd-4d746161fe29
Set id: 1a665e64-9f30-be37-4a83-38789f1f1e89
Version: 11
Effective Time: 20141223
 
Pfizer Consumer Healthcare