Ibuprofen

Cardinal Health

Ibuprofen, USP 200 mg

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Keep Out of Reach of Children
• Ibuprofen Uses
• Warnings
• Directions
• Inactive ingredients
• Storage
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

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)

Ibuprofen Uses

Temporarily relieves minor aches and pains due to: muscular aches, the common cold, temporarily reduces fever, headache, minor pain of arthritis, backache, menstrual cramps and toothache.

Warnings

This package is intended for institutional use only. Read all warnings and directions before use.

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. )

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, asthma (wheezing), skin reddening, facial-swelling, shock, rash and 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, if you have had stomach ulcers or bleeding problems, if you take a blood thinning (anticoagulant) or steroid drug, if you take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others], if you have 3 or more alcoholic drinks every day while using this product, or if you take more for a longer time than directed.

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer. Do not use 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, if stomach problems last or come back, such as heartburn, upset stomach, or stomach pain, ulcers, asthma, bleeding problems, high blood pressure, heart or kidney disease, taken a diuretic or have reached age 60 or older.

Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription), if you are taking a blood thinning (anticoagulant) or steroid drug, if you are under a doctor's care for any serious condition or if taking any other drug.

When using this product take with food or milk if stomach upset occurs or long term continuous use may 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. Stop use and ask a doctor if pain gets worse or lasts more than 10 days, if 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 or any new symptoms appear.

Read all warnings and directions before use.

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 Do Not Use.

Inactive ingredients

corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polythylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

Storage

Store at 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature]

Distributed by: MAJOR PHARMACEUTICALS

31778 Enterprise Drive, Livonia, MI 48150 USA

301559

Questions or Comments? (800) 616-2471

MFGD BY LNK, Hauppauge, NY 11788

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Ibuprofen Tablets, USP 200 mg

Pain Reliever/Fever Reducer (NSAID)

10 Tablets