ADVIL - ibuprofen tablet, coated 
Pfizer Consumer Healthcare

----------

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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever / Fever Reducer (NSAID)

100 Coated Tablets

See new warnings information

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.

Wyeth

For most recent product information, visit www.Advil.com

Wyeth Consumer Healthcare, Madison, NJ 07940 USA

©2010 Pfizer Inc.

Appearance of the brown Advil tablet is a trademark of Wyeth Consumer Healthcare

Advil Tablets Packaging

ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0150
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM  
FERRIC OXIDE RED 
METHYLPARABEN 
POVIDONE 
PROPYLPARABEN 
SHELLAC  
SILICON DIOXIDE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
WHITE WAX 
Product Characteristics
ColorBROWN (pinkish brown) Score no score
ShapeROUND (smooth in texture with polish surface) Size10mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0573-0150-201 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
120 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0150-20)
2NDC:0573-0150-301 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
250 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0150-30)
3NDC:0573-0150-401 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
3100 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0150-40)
4NDC:0573-0150-311 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
475 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0150-31)
5NDC:0573-0150-321 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
560 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0150-32)
6NDC:0573-0150-411 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
6125 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0150-41)
7NDC:0573-0150-421 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
7150 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0150-42)
8NDC:0573-0150-48325 TABLET, COATED ( TABLET) in 1 BOTTLENone

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE RED 
METHYLPARABEN 
POVIDONE 
PROPYLPARABEN 
SHELLAC 
SILICON DIOXIDE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
WHITE WAX 
Product Characteristics
ColorBROWN (pinkish brown) Score no score
ShapeOVAL (smooth in texture polished oval shaped tablet) Size15mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0573-0160-201 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
124 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0160-20)
2NDC:0573-0160-301 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
250 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0160-30)
3NDC:0573-0160-401 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
3100 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0160-40)
4NDC:0573-0160-251 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
436 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0160-25)
5NDC:0573-0160-311 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
575 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0160-31)
6NDC:0573-0160-411 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
6125 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0160-41)
7NDC:0573-0160-421 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
7150 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0160-42)

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:0573-0165
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (one hemisphere is brown while the other hemisphere is yellow) Score no score
ShapeCAPSULE (smooth in texture with polished surface) Size16mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0573-0165-201 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
124 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0165-20)
2NDC:0573-0165-301 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
250 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0165-30)
3NDC:0573-0165-401 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
3100 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0165-40)
4NDC:0573-0165-411 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
4125 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0165-41)
5NDC:0573-0165-421 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
5150 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0165-42)
6NDC:0573-0165-311 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
675 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0165-31)

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE RED 
METHYLPARABEN 
POVIDONE 
PROPYLPARABEN 
SHELLAC 
SILICON DIOXIDE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
WHITE WAX 
Product Characteristics
ColorBROWN (pinkish brown) Score no score
ShapeROUND (smooth in texture with polished surface) Size10mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0573-0154-351 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1150 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0154-35)
2NDC:0573-0154-751 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
2200 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0154-75)
3NDC:0573-0154-173000 POUCH ( POUCH) in 1 CASEcontains a POUCH
32 TABLET, COATED ( TABLET) in 1 POUCHThis package is contained within the CASE (0573-0154-17)
4NDC:0573-0154-8950 POUCH ( POUCH) in 1 CASEcontains a POUCH
42 TABLET, COATED ( TABLET) in 1 POUCHThis package is contained within the CASE (0573-0154-89)
5NDC:0573-0154-841 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
5225 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0154-84)

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE RED 
METHYLPARABEN 
POVIDONE 
PROPYLPARABEN 
SHELLAC 
SILICON DIOXIDE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
WHITE WAX 
Product Characteristics
ColorBROWN (pinkish brown ) Score no score
ShapeROUND (smooth in texture with polished suface) Size10mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0573-0151-1210 TABLET, COATED ( TABLET) in 1 VIALNone
2NDC:0573-0151-133 VIAL ( VIAL) in 1 PACKAGEcontains a VIAL
210 TABLET, COATED ( TABLET) in 1 VIALThis package is contained within the PACKAGE (0573-0151-13)
3NDC:0573-0151-1010 VIAL ( VIAL) in 1 PACKAGEcontains a VIAL
310 TABLET, COATED ( TABLET) in 1 VIALThis package is contained within the PACKAGE (0573-0151-10)
4NDC:0573-0151-211 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
436 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0151-21)
5NDC:0573-0151-141 VIAL ( VIAL) in 1 BLISTER PACKcontains a VIAL
510 TABLET, COATED ( TABLET) in 1 VIALThis package is contained within the BLISTER PACK (0573-0151-14)

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE RED 
METHYLPARABEN 
POVIDONE 
PROPYLPARABEN 
SHELLAC 
SILICON DIOXIDE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
WHITE WAX 
Product Characteristics
ColorBROWN (pinkish brown) Score no score
ShapeOVAL (smooth in texture polished oval shaped tablet ) Size15mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0573-0161-351 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1150 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0161-35)
2NDC:0573-0161-511 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
2200 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0161-51)
3NDC:0573-0161-851 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
3225 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0161-85)

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (one hemisphere is brown while the other hemisphere is yellow) Score no score
ShapeCAPSULE (smooth in texture with polished surface) Size16mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0573-0166-511 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1200 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (0573-0166-51)
2NDC:0573-0166-85225 TABLET, COATED ( TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984

Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company, Consumer Site829390975MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 07/2011 Pfizer Consumer Healthcare