ADVIL CapletsADVIL Gel CapletsADVIL Tablets(ibuprofen)

ADVIL - ibuprofen tablet, coated 
Pfizer Consumer Healthcare

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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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you

Do not use

Ask a doctor before use if

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

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

©2009 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 TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0150
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorBROWN (pinkish brown) Score no score
ShapeROUND (smooth in texture with polish surface) Size10mm
FlavorImprint Code Advil
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0150-201 BOTTLE In 1 CARTONcontains a BOTTLE
120 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-20)
20573-0150-301 BOTTLE In 1 CARTONcontains a BOTTLE
250 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-30)
30573-0150-401 BOTTLE In 1 CARTONcontains a BOTTLE
3100 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-40)
40573-0150-311 BOTTLE In 1 CARTONcontains a BOTTLE
475 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-31)
50573-0150-321 BOTTLE In 1 CARTONcontains a BOTTLE
560 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-32)
60573-0150-411 BOTTLE In 1 CARTONcontains a BOTTLE
6125 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-41)
70573-0150-421 BOTTLE In 1 CARTONcontains a BOTTLE
7150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-42)
80573-0150-48325 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 DRUGNDC Product Code (Source)0573-0160
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorBROWN (pinkish brown) Score no score
ShapeOVAL (smooth in texture polished oval shaped tablet) Size15mm
FlavorImprint Code Advil
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0160-201 BOTTLE In 1 CARTONcontains a BOTTLE
124 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-20)
20573-0160-301 BOTTLE In 1 CARTONcontains a BOTTLE
250 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-30)
30573-0160-401 BOTTLE In 1 CARTONcontains a BOTTLE
3100 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-40)
40573-0160-251 BOTTLE In 1 CARTONcontains a BOTTLE
436 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-25)
50573-0160-311 BOTTLE In 1 CARTONcontains a BOTTLE
575 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-31)
60573-0160-411 BOTTLE In 1 CARTONcontains a BOTTLE
6125 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-41)
70573-0160-421 BOTTLE In 1 CARTONcontains a BOTTLE
7150 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 DRUGNDC Product Code (Source)0573-0165
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
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
#NDCPackage DescriptionMultilevel Packaging
10573-0165-201 BOTTLE In 1 CARTONcontains a BOTTLE
124 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-20)
20573-0165-301 BOTTLE In 1 CARTONcontains a BOTTLE
250 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-30)
30573-0165-401 BOTTLE In 1 CARTONcontains a BOTTLE
3100 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-40)
40573-0165-411 BOTTLE In 1 CARTONcontains a BOTTLE
4125 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-41)
50573-0165-421 BOTTLE In 1 CARTONcontains a BOTTLE
5150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-42)
60573-0165-311 BOTTLE In 1 CARTONcontains a BOTTLE
675 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 DRUGNDC Product Code (Source)0573-0154
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorBROWN (pinkish brown) Score no score
ShapeROUND (smooth in texture with polished surface) Size10mm
FlavorImprint Code Advil
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0154-351 BOTTLE In 1 CARTONcontains a BOTTLE
1150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0154-35)
20573-0154-751 BOTTLE In 1 CARTONcontains a BOTTLE
2200 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0154-75)
30573-0154-173000 POUCH In 1 CASEcontains a POUCH
32 TABLET In 1 POUCHThis package is contained within the CASE (0573-0154-17)
40573-0154-8950 POUCH In 1 CASEcontains a POUCH
42 TABLET In 1 POUCHThis package is contained within the CASE (0573-0154-89)
50573-0154-841 BOTTLE In 1 CARTONcontains a BOTTLE
5225 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 DRUGNDC Product Code (Source)0573-0151
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorBROWN (pinkish brown ) Score no score
ShapeROUND (smooth in texture with polished suface) Size10mm
FlavorImprint Code Advil
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0151-1210 TABLET In 1 VIALNone
20573-0151-133 VIAL In 1 PACKAGEcontains a VIAL
210 TABLET In 1 VIALThis package is contained within the PACKAGE (0573-0151-13)
30573-0151-1010 VIAL In 1 PACKAGEcontains a VIAL
310 TABLET In 1 VIALThis package is contained within the PACKAGE (0573-0151-10)
40573-0151-211 BOTTLE In 1 CARTONcontains a BOTTLE
436 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0151-21)
50573-0151-141 VIAL In 1 BLISTER PACKcontains a VIAL
510 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 DRUGNDC Product Code (Source)0573-0161
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorBROWN (pinkish brown) Score no score
ShapeOVAL (smooth in texture polished oval shaped tablet ) Size15mm
FlavorImprint Code Advil
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0161-351 BOTTLE In 1 CARTONcontains a BOTTLE
1150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0161-35)
20573-0161-511 BOTTLE In 1 CARTONcontains a BOTTLE
2200 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0161-51)
30573-0161-851 BOTTLE In 1 CARTONcontains a BOTTLE
3225 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 DRUGNDC Product Code (Source)0573-0166
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
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
#NDCPackage DescriptionMultilevel Packaging
10573-0166-511 BOTTLE In 1 CARTONcontains a BOTTLE
1200 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0166-51)
20573-0166-85225 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
Revised: 06/2010Pfizer Consumer Healthcare