ADVIL- ibuprofen tablet, coated

Advil by

Drug Labeling and Warnings

Advil by is a Otc medication manufactured, distributed, or labeled by JC World Bell Wholesale Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

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 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:

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

ADVIL 
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50269-157(NDC:0573-0154)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	brown	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	Advil
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50269-157-01	6 in 1 BOX	05/18/1984
1		1 in 1 BLISTER PACK
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 50269-157-02	6 in 1 BOX	05/18/1984
2		2 in 1 BLISTER PACK
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 50269-157-03	25 in 1 BOX	05/18/1984
3		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018989	05/18/1984

Labeler - JC World Bell Wholesale Co., Inc. (805257581)