FDA Label for Excedrin Extra Strength

Active Ingredient (In Each Tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • a cold
  • arthritis
  • muscular aches
  • sinusitis
  • toothache
  • premenstrual & menstrual cramps
  
  

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 tables 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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.

Do Not Use

• if you have ever had an allergic reaction to 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
• high blood pressure
• you have asthma

Ask A Doctor Or Pharmacist Before Use

• 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 Doctor If

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs os 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
  
  

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.

Overdose Warning

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 (see Overdose Warning)
• drink a full glass of water with each dose
• adults and children 12 years and over: take 2 tablets  every 6 hours; not more than 8 tables  in 24 hours
• children under 12 years: ask a doctor

Other Information

• store at controlled room temperature 20⁰ -  25⁰ C (68⁰ -  77⁰ F)
• read all product information before using. Keep this box for important information

 

Inactive Ingredients

benzoic acid, carnauba wax, FD&C blue #1, hydroxypropyl cellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions Or Comments

1-800-468-7746

This product is supplied by State of Florida DOH Central Pharmacy as follows:

This product was Manufactured By:

Novartis Pharmaceuticals Corporation
One Health Plaza

And Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

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