FDA Label for Ibuprofen

View Indications, Usage & Precautions

Ibuprofen Product Label

The following document was submitted to the FDA by the labeler of this product Velocity Pharma. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



(in each tablet)

Ibuprofen 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
  • minor pains of arthritis
  • muscular aches
  • the common cold
  • temporarily reduces fever

Warnings



Allergy alert: This product may cause a severe allergic reaction, especially in people allergic to aspirin, symptoms may include

  • hives
  • facial swelling
  • asthma(wheezing)
  • shock
  • skin reddning
  • 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

      • this product if you have ever had an allergic reaction to any pain reliever/fever reducer
      • right before or after heart surgery
      • ask your 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
        • ask your 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 the benefit of aspirin
          • taking any other drug
          • when using this product

            • take with food or milk
            • The risk of heart attack or stroke may increase if you are more than directed or for longer than directed
            • Stop use and ask a doctor if:

              • you experience and 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 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
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persists.
  • 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: ask a doctor

Other Information



  • read all warnings and directions before use. keep carton
  • store at 20-25 °C (68-77 °F)
  • avoid excessive heat above 40°C (104°F)
  • do not use if imprinted safety seal under the cap is broken or missing

Inactive Ingredients



Colloidal silicon Dioxide, corn starch, Croscarmellose Sodium, hypermellose, Iron Oxide red, lactose monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, povidone, Pregelatinized Starch, stearic acid, Talc, Titanium Dioxide, triacetin


Questions Or Comments



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