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Generic: acetaminophen, aspirin, caffeine, salicylamide 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: EXA     SHAPE: round
    COLOR: orange

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Otc - Active Ingredient Section


Active Ingredients (in each tablet):

Acetaminophen 110mg

Aspirin (NSAID*) 162mg (*nonsteroidal anti-inflammatory drug)

Caffeine 32.4mg

Salicylamide (NSAID)* 152mg (*nonsteroidal anti-inflammatory drug)

Otc - Purpose Section


Purpose:

Pain Reliever / Fever Reducer

Pain Reliever / Fever Reducer

Pain Reliever Aid

Pain Reliever / Fever Reducer

Indications & Usage Section


Uses:

Temporarily relieves minor aches and pains due to
  • headache
  • backache
  • muscular aches
  • minor arthritis pain
  • the common cold
  • toothache
  • menstrual cramps

Temporarily reduces fever

Warnings Section


Warnings:

Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert: Acetaminophen and aspirin may cause severe allergic reactions which may include hives, skin reddening, bulers, rash, facial swelling, asthma (wheezing), or shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 4,000 mg of acetaminophen in 24 hours
  • with other products containing acetaminophen
  • 3 more 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 more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcohol drinks every day while using this product
  • take other drugs containing prescription or non-prescription NSAIDS (aspirin, ibuprofen, naproxen, others)

Otc - Do Not Use Section


Do not use
  • with any other drug containing acetaminophen (prescription or non-prescription)
  • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Otc - Ask Doctor Section


Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have asthma, 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

Otc - Ask Doctor/pharmacist Section


Ask a doctor or pharmacist before use if you
  • take any other drug containing an NSAID
  • take a blood thinning (anticoagulant) or steroid drug
  • take any drug for diabetes, gout, or arthritis
  • do not know if other drugs you are taking contain acetaminophen

Otc - Stop Use Section


Stop use and ask a doctor if
  • an allergic reaction occurs, seek medical help right away
  • new symptoms occur
  • fever worsens or lasts more than 3 days
  • pain worsens or lasts more than 10 days
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, or have bloody or black stools, or stomach pain that does not get better

These could be signs of a serious condition

Otc - Pregnancy Or Breast Feeding Section


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 is may cause problems in the unborn child or complications during delivery

Otc - Keep Out Of Reach Of Children Section


Keep out of reach of children

Overdosage Section


Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Dosage & Administration Section


Directions:

do not take more than directed.

Adults and children 12 years of age and over:
  • take 1 or 2 tablets with water every 4 hours while sympotms persist
  • do not take more than 8 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

Inactive Ingredient Section


Inactive Ingredients:

FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Starch, Stearic Acid

Package Label.principal Display Panel




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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