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
Active Ingredient (in each tablet) Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg
Otc - Purpose
Purpose-Pain reliever, Fever Reducer
Indications & Usage
Uses■ temporarily relieves pain due to:■ headache ■ muscular aches ■ colds ■ flu■ temporarily reduces fever
Dosage & Administration
- Directionsadults: take 2 tablets every 6 hours, not more than 8 tablets in24 hourschildren under 12 years: ask a doctor
WarningsReye's syndrome: Children and teenagers who have or arerecovering from chicken pox or flu-like symptoms should not usethis product. When using this product, if changes in behavior withnausea and vomiting occur, consult a doctor because thesesymptoms could be an early sign of Reye's syndrome, a rare butserious illness.Allergy alert: Aspirin may cause a severe allergic reaction whichmay include:■ hives ■ facial swelling ■ asthma (wheezing) ■ shockLiver warning: This product contains acetaminophen. Severeliver damage may occur if you take ■ more than 8 tablets in 24hours, 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 anonsteroidal anti-inflammatory drug (NSAID), which may causesevere 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 nonprescriptionNSAIDs (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 directedCaffeine warning: The recommended dose of this productcontains about as much caffeine as a cup of coffee. Limit the use ofcaffeine-containing medications, foods, or beverages while takingthis 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 any other painreliever/fever reducer■ with any other drug containing acetaminophen (prescriptionor nonprescription). If you are not sure whether a drugcontains acetaminophen, ask a doctor or pharmacist.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■ pain gets worse or lasts more than 10 days■ fever gets worse or lasts more than 3 days■ redness or swelling is present in the painful area■ any new symptoms appearAsk a doctor before use if you are taking a prescription drug for diabetes, gout, or arthritis■ stomach bleeding warning applies to you■ you have a history of stomach problems, such as heartburn you have asthma, high blood pressure, heart disease, live rdisease, or kidney disease■ you are taking a diuretic
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby, ask a health professional before use
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. In 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.
Inactive ingredients cellulose*, hydroxypropylmethylcellulose, maltodextrin*, polyethylene glycol, povidone,propylene glycol*, sodium lauryl sulfate*, sodium starchglycolate, starch, stearic acid, titanium dioxide*contains one or more of these ingredients
* Please review the disclaimer below.