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
muscular aches
minor pain of arthritis
toothache
backache
the common cold
menstrual cramps
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 chances are 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

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

you have problems or serious side effects from taking pain relievers or fever reducers
the stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
under a doctor’s care for any serious condition
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. (1-800-222-1222)

Directions

do not take more than directed
the smallest effective dose should be used
do not take longer than 10 days, unless directed by a doctor (see Warnings)

adults and children 12 years and older

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
store at 20-25°C (68-77°F)
avoid high humidity and excessive heat above 40°C (104°F)
see end panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxides, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

Questions or comments?

1-800-934-1204

Principal Display Panel

Compare to the Active Ingredient of Advil®

Ibuprofen

Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

See New Warnings Information

Gluten Free

Ibuprofen Label

BERKLEY AND JENSEN IBUPROFEN
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	68391-604
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (IBUPROFEN)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
TITANIUM DIOXIDE
POLYSORBATE 80
POLYETHYLENE GLYCOL

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	I2
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68391-604-62	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		24 TABLET In 1 BOTTLE	This package is contained within the CARTON (68391-604-62)
2	68391-604-90	500 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072096	06/20/2007

Labeler - BJWC (159082692)

Revised: 05/2009BJWC