FDA Label for Bufferin Regular Strength Pain Relief

Other

Drug Facts

Distributed by:
Genomma Lab USA Inc.
Houston, TX 77027

Active Ingredient (In Each Tablet)

Buffered aspirin equal to 325 mg aspirin (NSAID)

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains associated with:
  • headache
  • toothache
  • backache
  • muscular aches
  • headache
  • minor pain of arthritis
  • the common cold
  • premenstrual & menstrual cramps
  • temporarily reduces fever
  
  

Reye's Syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy Alert

Aspirin may cause a severe allergic reaction, which may include:

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

Stomach Bleeding Warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older
• have 3 or more alcoholic drinks every day while using this product
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• take more or for a longer time than directed

Do Not Use

• if you are allergic to aspirin or any other pain reliever/fever reducer
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If

• stomach bleeding warning applies to you
• you have asthma
• you have a history of stomach problems, such as heartburn
• you are taking a diuretic
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug for

• gout
• diabetes
• arthritis

Stop Use And Ask A Doctor If

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

  These could be signs of a serious condition.

  
  

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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.

Otc - 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 right away.

Directions

• drink a full glass of water with each dose
• adults and children 12 years and over: take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
• children under 12 years: do not use unless directed by a doctor

Other Information

• each tablet contains: calcium 35 mg and magnesium 40 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive Ingredients

anhydrous citric acid, corn starch, dibasic sodium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide

Questions Or Comments?

1-877-994-3666

Principal Display Panel - 325 Mg Table Bottle Carton

Regular Strength

Tough on pain. Gentler to your stomach.™

BUFFERIN^®
BUFFERED ASPIRIN (NSAID)

Pain Reliever
Fever Reducer

30 Coated Tablets 325 mg each

PRINCIPAL DISPLAY PANEL - 325 mg Table Bottle Carton - bufferin 01