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Generic Name: ibuprofen
Dosage Form: caplets, tablets

Advil Caplets
Advil Gel Caplets
Advil Tablets
(ibuprofen)

DRUG FACTS

ACTIVE INGREDIENT

Advil Tablets (in each tablet)

Ibuprofen 200 mg (NSAID)*

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*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

  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis
  • temporarily reduces fever

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 of age 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 of age 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 of age 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

  • read all warnings and directions before use. Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

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 
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 (Ibuprofen) Ibuprofen 200 mg
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
1 NDC:0573-0150-20 1 BOTTLE (BOTTLE) in 1 CARTON
1 20 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0150-30 1 BOTTLE (BOTTLE) in 1 CARTON
2 50 TABLET, COATED (TABLET) in 1 BOTTLE
3 NDC:0573-0150-40 1 BOTTLE (BOTTLE) in 1 CARTON
3 100 TABLET, COATED (TABLET) in 1 BOTTLE
4 NDC:0573-0150-31 1 BOTTLE (BOTTLE) in 1 CARTON
4 75 TABLET, COATED (TABLET) in 1 BOTTLE
5 NDC:0573-0150-32 1 BOTTLE (BOTTLE) in 1 CARTON
5 60 TABLET, COATED (TABLET) in 1 BOTTLE
6 NDC:0573-0150-41 1 BOTTLE (BOTTLE) in 1 CARTON
6 125 TABLET, COATED (TABLET) in 1 BOTTLE
7 NDC:0573-0150-42 1 BOTTLE (BOTTLE) in 1 CARTON
7 150 TABLET, COATED (TABLET) in 1 BOTTLE
8 NDC:0573-0150-48 325 TABLET, COATED (TABLET) in 1 BOTTLE
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 (ibuprofen) ibuprofen 200 mg
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
1 NDC:0573-0160-20 1 BOTTLE (BOTTLE) in 1 CARTON
1 24 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0160-30 1 BOTTLE (BOTTLE) in 1 CARTON
2 50 TABLET, COATED (TABLET) in 1 BOTTLE
3 NDC:0573-0160-40 1 BOTTLE (BOTTLE) in 1 CARTON
3 100 TABLET, COATED (TABLET) in 1 BOTTLE
4 NDC:0573-0160-25 1 BOTTLE (BOTTLE) in 1 CARTON
4 36 TABLET, COATED (TABLET) in 1 BOTTLE
5 NDC:0573-0160-31 1 BOTTLE (BOTTLE) in 1 CARTON
5 75 TABLET, COATED (TABLET) in 1 BOTTLE
6 NDC:0573-0160-41 1 BOTTLE (BOTTLE) in 1 CARTON
6 125 TABLET, COATED (TABLET) in 1 BOTTLE
7 NDC:0573-0160-42 1 BOTTLE (BOTTLE) in 1 CARTON
7 150 TABLET, COATED (TABLET) in 1 BOTTLE
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:0573-0165
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
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
# Item Code Package Description
1 NDC:0573-0165-20 1 BOTTLE (BOTTLE) in 1 CARTON
1 24 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0165-30 1 BOTTLE (BOTTLE) in 1 CARTON
2 50 TABLET, COATED (TABLET) in 1 BOTTLE
3 NDC:0573-0165-40 1 BOTTLE (BOTTLE) in 1 CARTON
3 100 TABLET, COATED (TABLET) in 1 BOTTLE
4 NDC:0573-0165-41 1 BOTTLE (BOTTLE) in 1 CARTON
4 125 TABLET, COATED (TABLET) in 1 BOTTLE
5 NDC:0573-0165-42 1 BOTTLE (BOTTLE) in 1 CARTON
5 150 TABLET, COATED (TABLET) in 1 BOTTLE
6 NDC:0573-0165-31 1 BOTTLE (BOTTLE) in 1 CARTON
6 75 TABLET, COATED (TABLET) in 1 BOTTLE
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 (ibuprofen) ibuprofen 200 mg
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
1 NDC:0573-0154-35 1 BOTTLE (BOTTLE) in 1 CARTON
1 150 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0154-75 1 BOTTLE (BOTTLE) in 1 CARTON
2 200 TABLET, COATED (TABLET) in 1 BOTTLE
3 NDC:0573-0154-17 3000 POUCH (POUCH) in 1 CASE
3 2 TABLET, COATED (TABLET) in 1 POUCH
4 NDC:0573-0154-89 50 POUCH (POUCH) in 1 CASE
4 2 TABLET, COATED (TABLET) in 1 POUCH
5 NDC:0573-0154-84 1 BOTTLE (BOTTLE) in 1 CARTON
5 225 TABLET, COATED (TABLET) in 1 BOTTLE
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 (ibuprofen) ibuprofen 200 mg
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
1 NDC:0573-0151-12 10 TABLET, COATED (TABLET) in 1 VIAL
2 NDC:0573-0151-13 3 VIAL (VIAL) in 1 PACKAGE
2 10 TABLET, COATED (TABLET) in 1 VIAL
3 NDC:0573-0151-10 10 VIAL (VIAL) in 1 PACKAGE
3 10 TABLET, COATED (TABLET) in 1 VIAL
4 NDC:0573-0151-21 1 BOTTLE (BOTTLE) in 1 CARTON
4 36 TABLET, COATED (TABLET) in 1 BOTTLE
5 NDC:0573-0151-14 1 VIAL (VIAL) in 1 BLISTER PACK
5 10 TABLET, COATED (TABLET) in 1 VIAL
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 (ibuprofen) ibuprofen 200 mg
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
1 NDC:0573-0161-35 1 BOTTLE (BOTTLE) in 1 CARTON
1 150 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0161-51 1 BOTTLE (BOTTLE) in 1 CARTON
2 200 TABLET, COATED (TABLET) in 1 BOTTLE
3 NDC:0573-0161-85 1 BOTTLE (BOTTLE) in 1 CARTON
3 225 TABLET, COATED (TABLET) in 1 BOTTLE
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 (ibuprofen) ibuprofen 200 mg
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
# Item Code Package Description
1 NDC:0573-0166-51 1 BOTTLE (BOTTLE) in 1 CARTON
1 200 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0166-85 225 TABLET, COATED (TABLET) in 1 BOTTLE
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 Operations
Wyeth Pharmaceuticals Company, Consumer Site 829390975 MANUFACTURE, ANALYSIS
Revised: 06/2010
 
Pfizer Consumer Healthcare



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