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  5. Label Information: Ibuprofen

FDA Label for Ibuprofen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES:
    4. OTHER
    5. DO NOT USE:
    6. ASK A DOCTOR BEFORE USE IF:
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE:
    8. WHEN USING THIS PRODUCT:
    9. STOP USE AND ASK A DOCTOR IF:
    10. IF PREGNANT OR BREAST-FEEDING:
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PRINCIPAL DISPLAY PANEL – 250 TABLET BOX LABEL

Ibuprofen Product Label

The following document was submitted to the FDA by the labeler of this product Wildman Business Group. 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
  • muscular aches
  • the common cold
  • backache
  • minor pain of arthritis
  • temporarily reduces fever
  • toothache
  • menstrual cramps

Other



Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

      • Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, asthma, or had a stroke
  • 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

When Using This Product:



  • take with food or milk if stomach upset occurs

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
    • you have symptoms of heart problems or stroke:
      • chest pain
      • weakness in one part or side of body
      • leg swelling
      • slurred speech
      • trouble breathing
      • pain gets worse or lasts more than 10 days
      • fever gets worse or lasts more than 3 days
      • any new symptoms appear
      • redness or swelling is present in the painful area

If Pregnant Or Breast-Feeding:



ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless specifically 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



Adults and children 12 years and over:

  • do not take more than directed
  • the smallest effective dose should be used
  • 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 exceed 6 tablets in 24 hours, unless directed by a doctor

      • Children under 12 years: ask a doctor


Other Information



  • read all product information before using
  • tamper evident. Do not use if packet is torn or opened
  • store between 68°-77°F (20°-25°C)
  • avoid excessive heat 104°F (40°C)
  • use by expiration date on package

Inactive Ingredients



carnauba wax, silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide


Principal Display Panel – 250 Tablet Box Label



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Ibuprofen

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