Bufferin

Ducere Pharma LLC

Bufferin

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Bufferin Uses
• Warnings
  • Reye's syndrome
  • Allergy alert
  • Stomach bleeding warning
• Directions
• Bufferin Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL - 130 Tablet Bottle Box

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Buffered aspirin equal to 325 mg aspirin (NSAID)nonsteroidal anti-inflammatory drug (buffered with magnesium carbonate, calcium carbonate and magnesium oxide)

Purpose

Pain reliever/fever reducer

Bufferin Uses

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

Warnings

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
• facial swelling
• shock
• asthma (wheezing)

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 if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

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

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

• 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
• an allergic reaction occurs
• symptoms do not improve
• ringing in the ears or loss of hearing occurs
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

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.

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.

Directions

• adults and children 12 years and over: 2 tablets with a full glass of water. Dosage may be repeated every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless directed by a doctor.
• children under 12 years: do not use unless directed by a doctor

Bufferin 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

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

Questions or comments?

1-800-790-6417

Distributed by:
Ducere Pharma, Somerville, NJ 08876 USA

PRINCIPAL DISPLAY PANEL - 130 Tablet Bottle Box

NDC 55741-013-13

Tough on pain. Gentler to your stomach.
than plain aspirin*

BUFFERIN^®

BUFFERED ASPIRIN (NSAID)

Pain Reliever/Fever Reducer

130 COATED TABLETS
325 mg EACH

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN