EXCEDRIN

Novartis Consumer Health, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• EXCEDRIN Uses
• Warnings
• Do not use
• Ask Doctor before use if
• Ask the doctor or pharmacist before use if you are
• Stop use and ask a doctor if
• Pregnancy or Breast Feeding
• Keep Out of Reach of Children
• Directions
• EXCEDRIN Other information
• Questions
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FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 250

Buffered aspirin equal to 250 mg aspirin (NSAID)*

(buffered with calcium carbonate)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

EXCEDRIN Uses

• for the temporary relief of minor aches and pains due to:
  • minor pain of arthritis
  • backache
  • muscular aches

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
• asthma (wheezing)
• shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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 have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask Doctor before use if

• you have liver disease
• 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 are taking a diuretic
• you have asthma

Ask the doctor or pharmacist before use if you are

• any other drug containing an NSAID (prescription or nonprescription)
• a blood thinning (anticoagulant) or steroid drug.
• a prescription drug for diabetes, gout, or arthritis
• any other drug, or are under a doctor’s care for any serious condition

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
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• ringing in the ears or loss of hearing occurs
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• any new symptoms appear

Pregnancy 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed
• drink a full glass of water with each dose
• adults and children 12 years and over: take 2  caplets every 6 hours; not more than 8 caplets in 24 hours
• children under 12 years: ask a doctor

EXCEDRIN Other information

• each caplet contains: calcium 80 mg
• store at controlled room temperature 20°-25°C (68°-77°F)
• read all product information before using. Keep this box for important information.

Questions

Questions or comments? 1-800-468-7746

Distr. By: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©20XX

Visit us at www.excedrin.com

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