The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
ACETAMINOPHEN 250 MGASPIRIN 250 MG (NSAID*)CAFFEINE 65 MG
* NONSTEROIDAL ANTI-INFLAMMATORY DRUG
Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Povidone, Pregelatinized Starch, Sodium Starch Gylolate, Stearic Acid, Titanium Dioxide
Otc - Purpose
PURPOSEPAIN RELIEVER - PAIN RELIEVER AID
Indications & Usage
USESTEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and menstrual cramps
Dosage & Administration
DIRECTIONSDO 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
KEEP OUT OF REACH OF CHILDRENIn case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
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 ALERTAspirin may cause a severe allergic reaction which may include:hivesfacial swellingasthma (sneezing)shockLIVER WARNING:This product contains acetaminophen. Severe liver damage may occur if you takemore 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 productSTOMACH 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 problemstake a blood-thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)take more or for a longer time than directedCAFFEINE 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.
* Please review the disclaimer below.