Ibuprofen

Label at a glance#

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-503-639-6300

Websitewww.westernfamily.comwww.westernfamily.com

Label contents#

Full prescribing information#

Active Ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Reliever/ Fever Reducer

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

• 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

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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 bet better
  • Pain gets worse or last more than 10 days
  • Fever gets worse or last more than 3 days
  • Redness or swelling is present in the painful area
  • Any new symptoms appear

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed
• the smallest effective dose should be used

Adults and children 12 years and older	take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years	ask a doctor

Other information

OTHER SAFETY 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 Wyeth consumer healthcare, owner of the registered trademark Advil®

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in ADVIL®†

Ibuprofen Caplets

Pain Reliever/ Fever Reducer (NSAID)*

Proudly distributed by Western family foods, Inc.

PO Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Manufactured by:

Granules India Limited

Madhapur, Hyderabad- 500 081, India.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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• Ibuprofen
• SILICON DIOXIDE
• STARCH, CORN
• DEXTROSE MONOHYDRATE
• HYPROMELLOSES
• FERRIC OXIDE RED
• LACTOSE MONOHYDRATE
• EGG PHOSPHOLIPIDS
• MALTODEXTRIN
• POVIDONES
• CARBOXYMETHYLCELLULOSE SODIUM
• SODIUM STARCH GLYCOLATE TYPE A CORN
• STEARIC ACID
• TITANIUM DIOXIDE
• TRIACETIN

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