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  5. Label Information: Ibuprofen (nsaid) Pain Releiver/ Fever Reducer

FDA Label for Ibuprofen (nsaid) Pain Releiver/ Fever Reducer

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. INDICATIONS AND USAGE
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE AND ADMINISTRATION
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS

Ibuprofen (nsaid) Pain Releiver/ Fever Reducer Product Label

The following document was submitted to the FDA by the labeler of this product Amneal Pharmaceuticals Of New York Llc. 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 caplet)

Ibuprofen USP, 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug


Purpose



Pain reliever/fever reducer


Indications And Usage



  • 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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

        • 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
          • taking any other drug containing an NSAID (prescription or nonprescription)
          • taking a blood thinning (anticoagulant) or steroid 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 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



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Dosage And Administration



  • do not take more than directed
  • the smallest effective dose should be used
    • Adults and children
    12 years and older
    • take 1 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets in 24 hours, unless directed by a doctor
    Children under
    12 years
    • ask a doctor

Other Information



  • Store between 20 - 25°C (68 - 77°F)
  • Read all warnings and directions before use

Inactive Ingredients



  • Brown Caplets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch Corn, Titanium Dioxide

    •  

      • Orange Caplets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, FD&C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide

        •  

Questions Or Comments



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