FDA Label for Ibuprofen

Active Ingredient (In Each Brown Tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

• Temporarily relieves minor aches and pains 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:

• shock
• hives
• facial swelling
• asthma (wheezing)
• 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 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 any other pain reliever/fever reducer
• right before or after heart surgery
  

Ask a doctor before use if

• the 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 lasts more than 10 days
• redness or swelling is present in the painful area
  
• fever gets worse or lasts more than 3 days
• any new symptoms occur
  

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

Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.

Directions

• do not use 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 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 take more than 6 tablets in 24 hours unless directed by a doctor
  
• children under 12 years: ask a doctor

Other Information

• store at controlled room temperature
• avoid excessive heat 40°C (104°F)

Inactive Ingredients

carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.

Questions Or Comments?

Call 1-800-540-3765

Principal Display Panel - 200 Mg Tablet Bottle Box Label

CommUnityCare Federally Qualified Health Centers

IBUPROFEN
200MG
TABS #100

Date:

Name:
Dr.

TAKE AS DIRECTED.

1/1/01

123456

IBUPROFEN 200MG TABS #100 NDC 76413-345-01

Batch:
123456
Lot:
123456
Exp:
1/1/01
HEALTHSTAR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 200 MG Tablet Bottle Box Label - ibuprofen 01