Ibuprofen

Western Family Foods, Inc.

DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient (in each tablet)
  • Purpose
• Ibuprofen Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding
  • Keep out of reach of children.
  • Directions
  • Ibuprofen Other information
• Inactive Ingredients
• Questions or comments?
• Principal Display Panel
• Package Labeling

FULL PRESCRIBING INFORMATION

Active Ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain Releiver/ Fever Reducer

Ibuprofen 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 an 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 oder
• have had stomach ulders or bleeding problems
• take blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks everyday while using this prdouct
• take more or for a longer time than directed.

Do not use

• if you 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 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 are taking a diuretic.

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
• 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 stoolos
  • have stomach pain that does not bet better
  • Pain gets worse or last more than 10 days
  • Fever gets worse or last more than 3 days
  • Redness or swelling is presentin 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 druing the last 3 months of pegnancy unless defintely 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

:

Other information

• store between 20^o- 25^o C (68^o- 77^o F)
• read all warnings and directions before use. Keep carton
• do not use if imprinted foil under cap is broken or missing
• †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil®

Inactive Ingredients

colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin

Questions or comments?

Call toll free 1-503-639-6300 Monday- Friday 9AM- 5PM PST

Principal Display Panel

Ibuprofen Coated Tablets 200 mg each

Pain Reliever/ Fever Reducer (NSAID)*

Compare to the active ingredient in ADVIL®†

SEE NEW WARNINGS INFORMATION

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Proudly distributed by

Western Family Foods, Inc.

P.O Box 4057, Portland, OR 97208 U.S.A

www.westernfamily.com

Manufactured by:

Granules India Limited

Madhapur, Hyderabad- 500081, INDIA

Package Labeling