EXTRA STRENGTH HEADACHE RELIEF (acetaminophen 250 mg aspirin 250 mg caffeine 65 mg) Dailymed

Otc - Active Ingredient Section

ACETAMINOPHEN 250 MG - ASPIRIN 250 MG (nsaid*) CAFFEINE 65 MG - * NONSTEROIDAL ANIT-INFLAMMATORY DRUG

Inactive Ingredient Section

STEARIC ACID MINERAL OIL SILICON DIOXIDE HYPROMELLOSES MICROCRYSTALLINE CELLULOSE STARCH, CORN POVIDONE CARNAUBA WAX TITANIUM DIOXIDE SODIUM STARCH GLYCOLATE

Otc - Purpose Section

PURPOSE

PAIN RELIEVER - PAIN RELIEVER AID

Indications & Usage Section

TEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and menstrual cramps

Dosage & Administration Section

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

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

Warnings Section

WARNINGS

REYE'S SYNDROME:

Children and teenagers who have or are recovering from chickenpox 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 (sneezing)

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)

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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heartbeat.

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