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.
Drug Facts - Acetaminophen/ Aspirin (Nsaid)/ Caffeine (370R)
ACETAMINOPHEN/ ASPIRIN (NSAID)/ CAFFEINE (370R)
Otc - Active Ingredient
Active ingredient (in each caplet) Purpose
Acetaminophen 250 mg. . . . . . . . . . . . . . . . . . . . . . .Pain reliever
Aspirin 250 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever
Caffeine 65 mg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pain reliever aid
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Pain relieverPain reliever aid
Indications & Usage
- Temporarily relieves minor aches and pains due to:
- Headachea coldarthritismuscular achestoothachepremenstrual 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:
- Hivesfacial swellingshockasthma (wheezing)Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddeningblistersrashIf 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 amountwith other drugs containing acetaminophen3 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 olderhave 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)have 3 or more alcoholic drinks every day while using this producttake 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 while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.
Otc - Do Not Use
- Do not usewith 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 doctorfor more than 3 days for fever unless directed by a doctor
Otc - Ask Doctor
- Ask a doctor before use ifstomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis or kidney diseaseyou are taking a diuretic
Otc - Ask Doctor/Pharmacist
- Ask a doctor or pharmacist before use if you aretaking a prescription drug for diabetes, gout, or arthritistaking any other drug or are under a doctor’s care for any serious condition
Otc - Stop Use
- Stop using and ask a doctor ifsymptoms do not improvenew symptoms occurpain or fever persists or gets worseyou experience any of the following signs of stomach bleeding:- feel faint- have bloody or black stools- vomit blood- have stomach pain that does not get betterringing 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
- Directionsdo not use more than directeddrink a full glass of water with each doseadults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hourschildren 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
Inactive ingredients: 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 1-877-290-4008
* Please review the disclaimer below.