ADVIL - ibuprofen tablet, coated 
Wyeth 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 Caps (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:

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

Advil Caplets

Advil Gel Caplets

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

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

©2008 Wyeth U.S. Patent No. 5,087,454

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

Advil Tablets Packaging

ADVIL 
ibuprofen   tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 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
No Inactive Ingredients Found
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
# NDC Package Description Multilevel Packaging
1 0573-0150-20 1 BOTTLE In 1 CARTON contains a BOTTLE
1 20 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0150-20)
2 0573-0150-30 1 BOTTLE In 1 CARTON contains a BOTTLE
2 50 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0150-30)
3 0573-0150-40 1 BOTTLE In 1 CARTON contains a BOTTLE
3 100 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0150-40)

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 NDC Product Code (Source) 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
No Inactive Ingredients Found
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
# NDC Package Description Multilevel Packaging
1 0573-0160-20 1 BOTTLE In 1 CARTON contains a BOTTLE
1 24 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0160-20)
2 0573-0160-30 1 BOTTLE In 1 CARTON contains a BOTTLE
2 50 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0160-30)
3 0573-0160-40 1 BOTTLE In 1 CARTON contains a BOTTLE
3 100 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0160-40)

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 NDC Product Code (Source) 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
No Inactive Ingredients Found
Product Characteristics
Color BROWN (one hemisphere is brown while the other hemisphere is yellow) Score no score
Shape CAPSULE (smooth in texture with polished surface) Size 16mm
Flavor Imprint Code Advil
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0573-0165-20 1 BOTTLE In 1 CARTON contains a BOTTLE
1 24 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0165-20)
2 0573-0165-30 1 BOTTLE In 1 CARTON contains a BOTTLE
2 50 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0165-30)
3 0573-0165-40 1 BOTTLE In 1 CARTON contains a BOTTLE
3 100 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0165-40)

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 NDC Product Code (Source) 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
No Inactive Ingredients Found
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
# NDC Package Description Multilevel Packaging
1 0573-0154-35 1 BOTTLE In 1 CARTON contains a BOTTLE
1 150 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0154-35)
2 0573-0154-75 1 BOTTLE In 1 CARTON contains a BOTTLE
2 200 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0154-75)
3 0573-0154-17 3000 POUCH In 1 CASE contains a POUCH
3 2 TABLET In 1 POUCH This package is contained within the CASE (0573-0154-17)
4 0573-0154-89 50 POUCH In 1 CASE contains a POUCH
4 2 TABLET In 1 POUCH This package is contained within the CASE (0573-0154-89)

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 NDC Product Code (Source) 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
No Inactive Ingredients Found
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
# NDC Package Description Multilevel Packaging
1 0573-0151-12 10 TABLET In 1 VIAL None
2 0573-0151-13 3 VIAL In 1 PACKAGE contains a VIAL
2 10 TABLET In 1 VIAL This package is contained within the PACKAGE (0573-0151-13)
3 0573-0151-10 10 VIAL In 1 PACKAGE contains a VIAL
3 10 TABLET In 1 VIAL This package is contained within the PACKAGE (0573-0151-10)

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 NDC Product Code (Source) 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
No Inactive Ingredients Found
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
# NDC Package Description Multilevel Packaging
1 0573-0161-35 1 BOTTLE In 1 CARTON contains a BOTTLE
1 150 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0161-35)
2 0573-0161-51 1 BOTTLE In 1 CARTON contains a BOTTLE
2 200 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0161-51)

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 NDC Product Code (Source) 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
No Inactive Ingredients Found
Product Characteristics
Color BROWN (one hemisphere is brown while the other hemisphere is yellow) Score no score
Shape CAPSULE (smooth in texture with polished surface) Size 16mm
Flavor Imprint Code Advil
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0573-0166-51 1 BOTTLE In 1 CARTON contains a BOTTLE
1 200 TABLET In 1 BOTTLE This package is contained within the CARTON (0573-0166-51)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984

Labeler - Wyeth Consumer Healthcare (828831730)
Revised: 06/2009 Wyeth Consumer Healthcare