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.
ACETAMINOPHEN/ ASPIRIN (NSAID)/ CAFFEINE
Otc - Active Ingredient
Active ingredient (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Pain reliever/Pain reliever aid
Indications & Usage
temporarily relieves minor aches and pains due to:
•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: Aspirin may cause a severe allergic reaction, which may include:
Allergyalert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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 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)
•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
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.
•for more than 10 days for pain unless directed by a doctor
•for more than 3 days for fever unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if
•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
Otc - Ask Doctor/Pharmacist
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
Otc - Stop Use
Stop using and ask a doctor if
•symptoms do not improve
•new symptoms occur
•pain or fever persists or gets worse
•you experience any of the following signs of stomach bleeding:
have bloody or black stools
have stomach pain that does not get better
•ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product.
Otc - Pregnancy Or Breast Feeding
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
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.
Dosage & Administration
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 years: ask a doctor
- Other informationstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)use by expiration date on package
carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide
Otc - Questions
Questions or comments?call 1-800-632-6900
* Please review the disclaimer below.