Excedrin Extra Strength Caplets (100)

Product Summary

Key Features and Uses:

Excedrin Extra Strength provides temporary fast-acting relief for minor aches and pains due to:

• headache
• a cold
• arthritis
• muscular aches
• toothache
• premenstrual & menstrual cramps

For some, headache relief starts in just 15 minutes. With 2 pain fighters and an amplifier, Excedrin Extra Strength helps you fight headaches, fast.

Excedrin Extra Strength's combination of active ingredients, acetaminophen, aspirin and caffeine, offers a fast-acting, non-prescription headache pain reliever alternative.

Dosage

Read all product information before using.

Tamper-evident bottle: do not use if the inner foil seal imprinted with "sealed for your protection" is broken or missing.

• Adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours.
• Under 12 years: ask a doctor.
• Do not use more than directed.
• Drink a full glass of water with each dose.

Keep the box for important information.

Ingredients

Active Ingredients: acetaminophen - 250 mg (pain reliever), aspirin (NSAID - 250 mg (pain reliever), caffeine - 65 mg (pain reliever aid).

Inactive Ingredients: benzoic acid, carnauba wax, FD&C Blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide.

Warnings and Restrictions

Read all product packaging and labels carefully prior to use.

• Do not give to children or teenagers who are recovering from chicken pox or flu-like symptoms because of the risk of Reye’s syndrome.
• Aspirin may cause severe allergic reactions.
• Acetaminophen may cause severe skin reactions.
• Acetaminophen may cause liver damage if you take more than the maximum recommended dosage, use with other medications that contain acetaminophen, or have more than 3 alcoholic drinks daily.
• The recommended dose contains about as much caffeine as a cup of coffee. Limit use of caffeine from other sources while taking this product.
• May cause stomach bleeding, especially in those over 60 years, previous stomach problems, taking a blood thinner or steroid, taking other NSAIDs, or taking more than 3 alcoholic drinks per day.
• Consult a doctor before using if you have high blood pressure, heart disease, liver cirrhosis, kidney disease, taking a diuretic, have asthma, or are taking medications for diabetes, gout, or arthritis.
• Consult a doctor or pharmacist if you have other medical conditions or are taking medications.
• See a doctor if symptoms get worse or persist for more than 10 days or if you have ringing in the ears.
• Ask a healthcare professional before use if pregnant or breastfeeding.

OTHER (EXTENDED) SAFETY CAUTIONS AND INFORMATION

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:

Acetaminophen may cause severe skin reactions. Symptoms may include skin reddening, blisters, or a rash. If a skin reaction occurs, stop use and seek medical help right away.

Aspirin may cause a severe allergic reaction which may include: hives, facial swelling, asthma (wheezing), or 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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• or 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 heartbeat.

Do not use this product 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 non-prescription).
• 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:

• 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, or seek medical help right away if:

• an allergic reaction occurs
• you experience any of the following signs of stomach bleeding: feeling faint, vomit blood, have bloody or black stools, have stomach pain that does not get better
• you experience ringing in the ears or loss of hearing occurs
• the painful area is red or swollen
• if the pain gets worse or lasts for more than 10 days
• if a fever gets worse or lasts for more than 3 days
• if any new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding:

• ask a health care 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:

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.

Storage

Store at room temperature between 20°C to 25°C (68-77°F).

Keep out of the reach of children.

Other information

Customer services:

• Company name: GSK Consumer Healthcare
• Return to: GSK Consumer Healthcare, Warren, NJ, 07059.

Questions or comments?:

• Telephone helpline: 1-800-452-0051
• Web Address: Visit www.excedrin.com