EXTRA STRENGTH PAIN RELIEVER Dailymed

Active Ingredients (in Each Caplet)

ACETAMINOPHEN 250 MG

ASPIRIN 250 MG (nsaid-nonsteroidal anti-inflammatory drug)

CAFFEINE 65 MG

Purposes

PAIN RELIEVER - PAIN RELIEVER AID

Uses

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 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • rash • skin reddening • bulers If a skin reaction occurs, stop use and seek medical help right away. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • 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 • 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) • are age 60 or older • 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 heartbeat.

Otc - Do Not Use Section

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.
• •if you have ever had an allergic reaction to this product or any of its ingredients

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
• •taking 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
• •new symptoms occur These could be signs of a serious condition.

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.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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: ask a doctor

Other Information

• •store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

1-800-540-3765

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