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 TypeHUMAN OTC DRUG LABELItem 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) Scoreno score
ShapeOVAL (smooth in texture with polished surface) Size16mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0165-201 in 1 CARTON
124 in 1 BOTTLE
2NDC:0573-0165-301 in 1 CARTON
250 in 1 BOTTLE
3NDC:0573-0165-401 in 1 CARTON
3100 in 1 BOTTLE
4NDC:0573-0165-411 in 1 CARTON
4125 in 1 BOTTLE
5NDC:0573-0165-421 in 1 CARTON
5150 in 1 BOTTLE
6NDC:0573-0165-311 in 1 CARTON
675 in 1 BOTTLE
7NDC:0573-0165-251 in 1 CARTON
736 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
POVIDONES 
PROPYLPARABEN 
SHELLAC 
SILICON DIOXIDE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
WHITE WAX 
DIACETYLATED MONOGLYCERIDES 
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeROUND (smooth in texture with polished surface) Size10mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0154-351 in 1 CARTON
1150 in 1 BOTTLE
2NDC:0573-0154-751 in 1 CARTON
2200 in 1 BOTTLE
3NDC:0573-0154-173000 in 1 CASE
32 in 1 POUCH
4NDC:0573-0154-8950 in 1 CASE
42 in 1 POUCH
5NDC:0573-0154-841 in 1 CARTON
5225 in 1 BOTTLE
6NDC:0573-0154-98300 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
POVIDONES 
PROPYLPARABEN 
SHELLAC 
SILICON DIOXIDE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
WHITE WAX 
DIACETYLATED MONOGLYCERIDES 
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeROUND (smooth in texture with polished suface) Size10mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0151-1210 in 1 VIAL
2NDC:0573-0151-133 in 1 PACKAGE
210 in 1 VIAL
3NDC:0573-0151-1010 in 1 PACKAGE
310 in 1 VIAL
4NDC:0573-0151-211 in 1 CARTON
436 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
POVIDONES 
PROPYLPARABEN 
SHELLAC 
SILICON DIOXIDE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
WHITE WAX 
DIACETYLATED MONOGLYCERIDES 
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeOVAL (smooth in texture polished oval shaped tablet) Size15mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0161-351 in 1 CARTON
1150 in 1 BOTTLE
2NDC:0573-0161-511 in 1 CARTON
2200 in 1 BOTTLE
3NDC:0573-0161-851 in 1 CARTON
3225 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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) Scoreno score
ShapeOVAL (smooth in texture with polished surface) Size16mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0166-511 in 1 CARTON
1200 in 1 BOTTLE
2NDC:0573-0166-85225 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
POVIDONES 
PROPYLPARABEN 
SHELLAC 
SILICON DIOXIDE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
WHITE WAX 
DIACETYLATED MONOGLYCERIDES 
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeROUND (smooth in texture with polish surface) Size10mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0150-201 in 1 CARTON
124 in 1 BOTTLE
2NDC:0573-0150-301 in 1 CARTON
250 in 1 BOTTLE
3NDC:0573-0150-401 in 1 CARTON
3100 in 1 BOTTLE
4NDC:0573-0150-311 in 1 CARTON
475 in 1 BOTTLE
5NDC:0573-0150-321 in 1 CARTON
560 in 1 BOTTLE
6NDC:0573-0150-411 in 1 CARTON
6125 in 1 BOTTLE
7NDC:0573-0150-421 in 1 CARTON
7150 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
POVIDONES 
PROPYLPARABEN 
SHELLAC 
SILICON DIOXIDE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
WHITE WAX 
DIACETYLATED MONOGLYCERIDES 
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeOVAL (smooth in texture polished oval shaped tablet) Size15mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0160-201 in 1 CARTON
124 in 1 BOTTLE
2NDC:0573-0160-301 in 1 CARTON
250 in 1 BOTTLE
3NDC:0573-0160-401 in 1 CARTON
3100 in 1 BOTTLE
4NDC:0573-0160-251 in 1 CARTON
436 in 1 BOTTLE
5NDC:0573-0160-311 in 1 CARTON
575 in 1 BOTTLE
6NDC:0573-0160-411 in 1 CARTON
6125 in 1 BOTTLE
7NDC:0573-0160-421 in 1 CARTON
7150 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company, Consumer Site829390975ANALYSIS(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)

Revised: 6/2014
Document Id: 266de2b8-e01a-4a11-90ef-006080d60576
Set id: 1a665e64-9f30-be37-4a83-38789f1f1e89
Version: 8
Effective Time: 20140613
 
Pfizer Consumer Healthcare