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  4. Postmarket Drug Safety Information for Patients and Providers
  5. Ibuprofen Drug Facts Label
  1. Postmarket Drug Safety Information for Patients and Providers

Ibuprofen Drug Facts Label

Drug Facts 

Active ingredient (in each tablet or capsule)                                                
Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose
Pain reliever/fever

Uses
temporarily relieves minor aches and pains due to: 

  • headache
  • minor pain of arthritis
  • the common cold  
  • muscular aches
  • temporarily reduces fever
  • backache       
  •  toothache  
  • menstrual cramps    

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
  • blister

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

  • take a blood thinning (anticoagulant) or steroid drug

  • take other drugs containing an NSAID [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 you have

  • problems or serious side effects from taking pain relievers or fever reducers

  • 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

  • taken a diuretic

  • 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)

  • taking a blood thinning (anticoagulant) or steroid drug

  • 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

  • long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

  • you feel faint, vomit blood, or have bloody or black stools.  These are signs of stomach bleeding.

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

  • stomach pain or upset gets worse or lasts

  • 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.

Directions

  • 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)

  • Refer to the product container for additional directions

Other information 
Refer to the specific product container for this information.

Inactive Ingredients
The specific product container has an alphabetical list of the inactive ingredients included in the product.

Questions or comments?
This section is not always present.  If it is included, this section often lists an 800 number as well as times to call with questions or comments.

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