Motrin ® IB

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to: headachemuscular achesminor pain of arthritistoothachebackachethe common coldmenstrual cramps
• temporarily reduces fever

Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

• hives
• facial swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chances are 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 prescription or nonprescription NSAIDs [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 ibuprofen or 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
• 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

• 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 faintvomit bloodhave bloody or black stoolshave stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

• read all warnings and directions before use
• store at 20-25°C (68-77°F)
• avoid high humidity and excessive heat above 40°C (104°F)
• do not use if pouch is torn or damaged

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC. McNeil Consumer Healthcare Division Fort Washington, PA 19034 USA

Repackaged and distributed by Convenience Valet ®, Glendale Heights, IL 60139

Mortin CVP 4 Count Carton

See Revised Warnings

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[caplet image]

4 Coated Caplets**

2 POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

CVP

HEALTH