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Generic: acetaminophen, aspirin and caffeine is used for the treatment of Arthritis, Rheumatoid Blood Coagulation Disorders Blood Platelet Disorders Cerebral Infarction Ischemic Attack, Transient Chickenpox Child, Preschool Fever Gout Hematemesis Hemorrhagic Disorders Infant Inflammation Melena Myocardial Infarction Nasal Polyps Osteoarthritis Pain Pre-Eclampsia Pregnancy Trimester, Third Rheumatic Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Apnea Fatigue


IMPRINT: TCL370     SHAPE: capsule
    COLOR: white

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Active Ingredients


ACETAMINOPHEN 250 MG

ASPIRIN 250 MG (nsaid*)

CAFFEINE 65 MG * NONSTEROIDAL ANIT-INFLAMMATORY DRUG

Inactive Ingredients


Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Povidone, Pregelatinized Starch, Sodium Starch Gylolate, Stearic Acid, Titanium Dioxide

Otc - Purpose Section


PAIN RELIEVER - PAIN RELIEVER AID

Directioins


DO NOT USE MORE THAN DIRECTED - DRINK A FULL GLASS OF WATER WITH EACH DOSE - ADULTS AND CHILDREN 12 YEARS AND OVER TAKE 2 TABLETS EVERY 6 HOURS, NOT MORE THAN 8 TABLETS IN 24 HOURS .

Uses


TEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and menstrual cramps

Otc - Do Not Use Section


Do not use if you have ever had an allergic reaction to acetaminophe, aspirin or any other pain reliever/fever reducer; with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Warnings


REYE'S SYNDROME:

Children and teenages 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 eary sign of Reye's syndrome, a rare but serious illnes.

ALLERY ALERT

Aspirin may cause a severe allergic reaction which may include:

hives

facial swelling

asthma (sheezing)

shock

LIVER WARNING:

This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 tablets in 24 hours, which is the maximum daily amount;

with other drugs containing acetaminophen;

3 or more alcoholic drinks every day while usng 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 (anticogulant) 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

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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.

Otc - Keep Out Of Reach Of Children Section


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 any sighs or symptoms

Pregnancy Section


If Pregnant or breast-feeding ask a helth 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 becausde it may cause prombles inthe unborn child or complications during delivery.

Package Label.principal Display Panel


NDC 50268-053-15 EXTRA PAIN RELIEF Acetaminophen, Aspirin (NSAID) and Caffeine EXTRA STREGTH 50 Tablets (5 X 10) Unit Dose 5026805315 NDC 50268-053-15 EXTRA PAIN RELIEF Acetaminophen, Aspirin (NSAID) and Caffeine EXTRA STREGTH 50 Tablets (5 X 10) Unit Dose 5026805315

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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