Ibuprofen

Cardinal Health

Ibuprofen 200 mg

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Ibuprofen USP 200mg (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.

This unit dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.

Ibuprofen Uses

Temporarily relieves minor aches and pains due to: headache, the common cold, toothache, muscular aches, backache, minor pain of arthritis, menstrual cramps and 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 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, 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 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 or 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 you have 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, asthma, taken a diuretic or 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, if you are taking aspirin to prevent heart attack or stroke because ibuprofen may decrease this benefit of aspirin or if you are 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 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 gets worse or lasts more than 3 days, stomach pain or upset gets worse or lasts, if redness or swelling is present in the painful area or if 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.

TAMPER-EVIDENT: each tablet is individually sealed. Do not use if blister is torn or broken.

Directions

Read all warnings and directions before use.

• 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 of age and over: 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

Inactive ingredients

Acacia, calcium carbonate, carnauba wax, confectioner's sugar, crospovidone, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, pregelatinized starch, silicone dioxide, sodium benzoate, starch, sucrose, talc, titanium dioxide, white wax.

STORAGE:

Store at 20-25 C (68-77 F) avoid excessive heat above 40 C (104 F).

Manufactured for:

GOLDLINE LABORATORIES, INC

Sellersville, PA 18960

by: Ohm Laboratories, Inc.

North Brusnwick, NJ 08902

Questions? call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

REPACKAGED BY Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Ibuprofen, USP

200 mg

10 Tablets