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EXCEDRIN (acetaminophen 250 mg aspirin 250 mg) Dailymed



IMPRINT: EBB     SHAPE: capsule
    COLOR: green

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Active Ingredients (in Each Caplet)


Acetaminophen 250 mg

Buffered aspirin equal to 250 mg aspirin (NSAID)*

(buffered with calcium carbonate)

*nonsteroidal anti-inflammatory drug

Purposes


Pain reliever

Pain reliever

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

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 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 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 arthiritis
  • •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
    • ofeel faint
    • ovomit blood
    • ohoave bloody or black stools
    • ohave 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

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 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

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.

Inactive Ingredients


benzoic acid, D&C yellow #10 lake, FD&C blue #1 lake, FD&C blue #2 lake, hydroxypropylcellulose, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, polysorbate 80, povidone, pregelatinized starch, silicone dioxide, stearic acid, talc, zinc stearate

Questions Or Comments?


1-800-468-7746

Principal Display Panel


NDC 0067-6238-24

EXCEDRIN

BACK & BODY

EXTRA STRENGTH

Acetaminophen and Buffered Aspirin (NSAID)

Pain Reliever

See new warnings information

24 BI-LAYER CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SELAED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 USA

©2009

Visit us at www.excedrin.com

2005826A

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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