Excedrin

Novartis Consumer Health, Inc.

Excedrin® MENSTRUAL COMPLETEAcetaminophen, Aspirin (NSAID) and Caffeine Pain Releiver/Diuretic Express Gels™ Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Excedrin Uses
• Warnings
• Allergy Alert
• Do not use
• Ask Doctor
• Ask Doctor or Pharmacist
• Stop Use
• Pregnancy or Breast Feeding
• Keep Out of Reach of Children
• Overdose
• Directions
• Excedrin Other information
• Inactive ingredients
• Questions
• Principal Display

FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients (in each gelcap)

Acetaminophen 250 mg 

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Diuretic

Excedrin Uses

• temporarily relieves minor aches and pains due to:

• muscular aches • headache • backache • premenstrual & menstrual cramps

• temporarily relieves these symptoms associated with menstrual periods:

• water-weight gain • bloating • swelling • full feeling • fatigue

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.

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

• more than 8 gelcaps 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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Allergy Alert

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

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

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

Ask a 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 Doctor or Pharmacist

Ask a doctor or pharmacist before use if you are taking:

• 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

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

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

Keep out of reach of children.

Overdose

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 gelcaps  every 4-6 hours; not more than 8 gelcaps in 24 hours
• children under 12 years: ask a doctor

Excedrin Other information

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

Inactive ingredients

benzoic acid, D&C red # 28, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, hypromellose, light mineral oil, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions

Questions or comments? 1-800-468-7746

Distr. By: Novartis Consumer Health, Inc.

 Parsippany, NJ 07054-0622 ©2009

Visit us at www.excedrin.com

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