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 ingredients (in each caplet)Acetaminophen 250 mg.Aspirin (NSAID*) 250 mgCaffeine 65 mg*nonsteroidal anti-inflammatory drug
Otc - Purpose
PurposePain reliever/fever reducerPain reliever/fever reducerPain reliever aid
Indications & Usage
Usestemporarily relieves minor aches and pains due to■ headache ■ muscular aches ■ arthritis pain ■ a cold
■ toothache ■ premenstrual and menstrual cramps
WarningsReye'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 ■ rashIf a skin reaction occurs, stop use and seek medical help right away.Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:
■ hives ■ facial swelling ■ asthma (wheezing) ■ shockLiver 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 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 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■ have 3 or more alcoholic drinks every day while using this productCaffeine 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 heart beat
Otc - Do Not Use
Do not use■ 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 ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/ fever reducers
Otc - Ask Doctor
Ask a doctor before use if■ stomach bleeding warning applies to you■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease■ you are taking a diuretic■ you have a history of stomach problems such as heartburn■ you have asthma■ you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are■ taking a prescription drug for gout, diabetes, or arthritis■ taking any other drug, or under a doctor’s care for any serious condition
Otc - Stop Use
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■ pain gets worse or lasts more than 10 days■ fever gets worse or lasts more than 3 days■ ringing in the ears or loss of hearing occurs■ painful area is red or swollen■ any new symptoms appearThese could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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.
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. Quick medical attention is critical for adults as well as for children even if you do not notice anysigns or symptoms.
Dosage & Administration
do not use more than directed■ drink a full glass of water with each doseAdults and children: (12 years and over) Take 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours
Children under 12 years: ask a doctor
Other Safety Information
Other information■ read all product information before using. Keep box for important information.■ store at room temperature 68º-77ºF (20º-25ºC)■ avoid excessive heat and humidity■ tamper evident sealed packets■ do not use any opened or torn packets■
each caplet contains: Magnesium 0.58 mg
Inactive ingredientscolloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc
Otc - Questions
Questions or comments? 1-800-634-7680
* Please review the disclaimer below.