FDA Label for Ibuprofen

Active Ingredient(S)

Ibuprofen 200mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Use(S)

• 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 and seek medical help right away.

Stomach bleeding warning:This product contains an  NSAID, which may cause stomach

bleeding. The chances is 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 for longer than directed

Stop Use And Ask Doctor If

• 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 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

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.

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

Storage

• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

• do not use if foil inner seal is broken or  missing.

• see end panel for lot number and expiration date

Inactive Ingredients

colloidal silicon dioxide, FD&C Yellow #6, hypromellose, maize starch, polydextrose, polyethylene glycol,

povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide.

Questions or comments?

Contact 1-877-770-3183

Mon-Fri 9:00 AM to 4:30 PM EST

Manufactured By:

Granules India Limited

Hyderabad – 500 081, INDIA

MADE IN INDIA

Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054

Toll-free: 1-877-770-3183

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