IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER - ibuprofen tablet 
Amneal Pharmaceuticals

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Ibuprofen Tablets, USP (NSAID)
Pain Reliever/ Fever Reducer

*Compared to the active ingredient of Advil®

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
• muscular aches
• minor pain or 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 NSAID (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
• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or older

Ask a doctor or pharmacist before use if you are

• taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin
• taking any other drug containing an NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid drug
• 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
• long term continuous use ay increase the risk of heart attack or stroke

Stop use and ask a doctor if

• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• stomach pain or upset gets worse or lasts
• 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 (1-800-222-1222) right away.

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 a 24-hour period
Children under 12 years	ask a doctor

Other information

• store at 20 – 25°C (68 – 77°F).
• Read all warnings and directions before use

Inactive ingredients

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide.

Questions or Comments?

Call 1-877-835-5472

Monday though Friday 9AM – 5PM EST.

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®

Rev. 10-2008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IBUPROFEN (NSAID)  PAIN RELEIVER/ FEVER REDUCER ibuprofen (nsaid)   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 53746-140 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 ANHYDROUS LACTOSE   CARNAUBA WAX   SILICON DIOXIDE   HYPROMELLOSE   FERRIC OXIDE RED   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYDEXTROSE   POLYETHYLENE GLYCOL   POVIDONE   SODIUM LAURYL SULFATE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STARCH, CORN   TITANIUM DIOXIDE

Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code IP;140 Contains

Packaging # NDC Package Description Multilevel Packaging 1 53746-140-01 100 TABLET In 1 BOTTLE None 2 53746-140-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071333	12/16/2009

Labeler - Amneal Pharmaceuticals (831227801)

Registrant - Amneal Pharmaceuticals (831227801)

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals		831227801	ANALYSIS, MANUFACTURE

Revised: 12/2009Amneal Pharmaceuticals