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Advil by Wyeth Consumer Healthcare LLC

Dosage form: tablet, coated
Ingredients: IBUPROFEN SODIUM 256mg
Labeler: Wyeth Consumer Healthcare LLC
NDC Code: 0573-0133

ADVIL
ibuprofen sodium tablet, coated

Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (provided as ibuprofen sodium 256 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 nonprescription 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

Heart attack and stroke warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, asthma, or had a stroke
  • 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

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
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • 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

  • 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

Other information

  • each tablet contains: sodium 22 mg
  • 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

acesulfame potassium, caramel color, carnauba wax, colloidal silicon dioxide, copovidone, ferric oxide, hypromellose, mannitol, medium-chain triglycerides, microcrystalline cellulose, natural and artificial flavor, pharmaceutical ink, polyethylene glycol, propylene glycol, sodium lauryl sulfate, sucralose, titanium dioxide

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

For most recent product information, visit www.Advil.com
Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 80 Tablet Bottle Label

Advil®

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

FILM-COATED
IBUPROFEN
SODIUM

80 Tablets

PRINCIPAL DISPLAY PANEL - 80 Tablet Bottle Carton

Advil®

FILM-COATED
IBUPROFEN
SODIUM

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Tablets

80 Tablets

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

Advil®

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

FILM-COATED
IBUPROFEN
SODIUM

100 Tablets

80+20 FREE
Tablets

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

Advil®

20
FREE
TABLETS

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

FILM-COATED
IBUPROFEN
SODIUM

Tablets

100
Tablets

PRINCIPAL DISPLAY PANEL - 180 Tablet Bottle Carton

FREE
20ct BOTTLE

BUY
160
+
GET
20

Advil®

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

180
Tablets

FILM-COATED
IBUPROFEN
SODIUM

Tablets

ADVIL 
ibuprofen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0133
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN SODIUM (IBUPROFEN) IBUPROFEN SODIUM256 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CARAMEL 
CARNAUBA WAX 
SILICON DIOXIDE 
COPOVIDONE K25-31 
FERRIC OXIDE RED 
HYPROMELLOSE, UNSPECIFIED 
MANNITOL 
MEDIUM-CHAIN TRIGLYCERIDES 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
SUCRALOSE 
TITANIUM DIOXIDE 
Product Characteristics
ColorBROWN (beige) Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeAdvil;asymmetrical;underline
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0133-201 BOTTLE in 1 CARTON
120 TABLET, COATED in 1 BOTTLE
2NDC:0573-0133-401 BOTTLE in 1 CARTON
240 TABLET, COATED in 1 BOTTLE
3NDC:0573-0133-801 BOTTLE in 1 CARTON
380 TABLET, COATED in 1 BOTTLE
4NDC:0573-0133-0250 PACKET in 1 TRAY
42 TABLET, COATED in 1 PACKET
5NDC:0573-0133-042 PACKET in 1 BLISTER PACK
52 TABLET, COATED in 1 PACKET
6NDC:0573-0133-891 BOTTLE in 1 CARTON
6160 TABLET, COATED in 1 BOTTLE
7NDC:0573-0133-811 BOTTLE in 1 CARTON
7100 TABLET, COATED in 1 BOTTLE
8NDC:0573-0133-052 PACKET in 1 CARTON
82 TABLET, COATED in 1 PACKET
9NDC:0573-0133-882 BOTTLE in 1 PACKAGE
9120 TABLET, COATED in 1 BOTTLE
10NDC:0573-0133-411 BOTTLE in 1 CARTON
1040 TABLET, COATED in 1 BOTTLE
11NDC:0573-0133-911 BOTTLE in 1 CARTON
11180 TABLET, COATED in 1 BOTTLE
12NDC:0573-0133-013000 PACKET in 1 CASE
122 TABLET, COATED in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20180307/08/2013
ADVIL 
ibuprofen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0134
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN SODIUM (IBUPROFEN) IBUPROFEN SODIUM256 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CARAMEL 
CARNAUBA WAX 
SILICON DIOXIDE 
COPOVIDONE K25-31 
FERRIC OXIDE RED 
HYPROMELLOSE, UNSPECIFIED 
MANNITOL 
MEDIUM-CHAIN TRIGLYCERIDES 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
SUCRALOSE 
TITANIUM DIOXIDE 
Product Characteristics
ColorBROWN (beige) Scoreno score
ShapeOVALSize15mm
FlavorImprint CodeAdvil;asymmetrical;underline
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0134-201 BOTTLE in 1 CARTON
120 TABLET, COATED in 1 BOTTLE
2NDC:0573-0134-801 BOTTLE in 1 CARTON
280 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20180307/08/2013
Labeler - Wyeth Consumer Healthcare LLC (828831730)
Registrant - Pfizer Inc (113480771)
Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0133, 0573-0134), LABEL(0573-0133, 0573-0134), MANUFACTURE(0573-0133, 0573-0134), PACK(0573-0133, 0573-0134)

 
Wyeth Consumer Healthcare LLC

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Medically reviewed on Jun 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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