ADVIL- ibuprofen tablet, coated 
JC World Bell Wholesale Co., Inc.

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Advil

Drug Facts

Active ingredient (in each tablet)

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 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 aspiritin • taking any other drug

When using this product

• take with food or milk if stomach upset occurs

Stop use and aIf pregnant or breast-feeding,sk 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 at 20 weeks or later in 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

• 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

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

Questions or comments?

call toll free 1-800-88-ADVIL

Package Labeling:

Outer PackageInner Package

Package Labeling:

Outer Package2Inner Package2

Package Labeling:

Label

ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-157(NDC:0573-0154)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize11mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50269-157-016 in 1 BOX05/18/1984
11 in 1 BLISTER PACK
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:50269-157-026 in 1 BOX05/18/1984
22 in 1 BLISTER PACK
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:50269-157-0325 in 1 BOX05/18/1984
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
Labeler - JC World Bell Wholesale Co., Inc. (805257581)

Revised: 7/2024
Document Id: 1d9a93eb-909b-a668-e063-6394a90a6533
Set id: 0b83c9ed-3630-4c5c-9020-cf38183a6500
Version: 4
Effective Time: 20240719
 
JC World Bell Wholesale Co., Inc.