FDA Label for Ibuprofen

Active Ingredient (In Each Tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti- inflammatory drug 

Purpose

Pain Reliever/ Fever Reducer

Uses

temporarily relieves minor aches and pain due to:

• headache
• toothache
• backache
• menstrual cramps
• the common cold
• muscular aches
• minor pain of arthritis
• 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 severe stomach bleeding. The chance 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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks everyday 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 any other pain reliever/ fever reducer
  
• right before or after heart surgery
  

Ask A Doctor Before Use If

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
• you are taking a diuretic
  

Ask A Doctor Or Pharmacist Before Use If You Are

• under a doctor's care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  
• 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 faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better
• pain gets worse or last for 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,

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). This Package for Households Without Young Children.

Directions

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

adults and children 12 years and older	take 1 tablet every4 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	consult a doctor

Other Information

• Tamper Evident: do not use if safety seal under cap is broken or missing
• store at room temperature (20^o- 25^oC) 
• avoid excessive heat above 40^oC (104^oF)

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, red iron oxide, talc & titanium dioxide  

Questions? Adverse Drug Event Call: (866)562-2756 Mon-Fri: 8 Am To 4 Pm

*This product is not manufactured or distributed by Pfizer Consumer Products, owner of the registered trademark ADVIL^®.

Manufactured for:

Pharbest Pharmaceuticals, Inc.,

Farmingdale, NY 11735

LRev 02/16