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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. WARNINGS
    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. QUESTIONS? ADVERSE DRUG EVENT CALL: (800)687-0176
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. 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 pain due to
  • minor pain of arthritis
  • headache
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • muscular aches
  • 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 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 non prescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks everyday 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



  • 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 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 last for more than 10 days
  • fever gets worse or last 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



In case of overdose, get medical help or contact a poison control center right away.This package is not for households with young children.

Directions



  • do not take more than directed
    • the smallest effective dose should be used

      • Adults and children
      12 years and older
      • take 1 tablet every4 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



  • store between 20o- 25oC (68o- 77oF)
  • avoid high humidity and excessive heat above 40oC (104oF)

Inactive Ingredients:



Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DC yellow# 10, FDC blue# 2, FDC red# 40, FDC yellow# 6, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, red iron oxide, titanium dioxide

Questions? Adverse Drug Event Call: (800)687-0176



*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark ADVIL®.

Package Label.Principal Display Panel



Ibuprofen 200 mg (NSAID)*

NDC 54868-0984-4

SDA Ibuprofen 200 mg Brown Tablet - 0984

SDA Ibuprofen 200 mg Brown Tablet - 0984




Additional bar code label applied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146


* Please review the disclaimer below.