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Generic: acetaminophen, aspirin, 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


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Drug Facts


Drug Facts

Active Ingredients And Purposes


OTC - PURPOSE SECTION

Active ingredients Purposes
Acetaminophen 250 mg................... Pain reliever
Aspirin (NSAID*) 250 mg ................ Pain reliever
Caffeine 65 mg................................. Pain reliever aid/ diuretic

* nonsteroidal anti-inflammatory drug

Uses


Temporarily relieves minor aches and pains due to:
  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps and bloating

Warnings


Reye'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 (NSAID) may cause a severe allergic reaction which may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Liver warning: This product contains Acetaminophen. Severe liver damage may occur if
  • adult takes more than 4 doses in 24 hours, which is the maximum daily amount
  • child takes more than 3 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday while using this product

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if the user:
  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • takes more or for a longer time than directed
  • has 3 or more alcoholic drinks everyday while using this product

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 a rapid heartbeat.

Do not use

  • if the user has ever had an allergic reaction to acetaminophen, 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.

Ask a doctor before use if the user

  • has liver disease
  • has a history of stomach problems, such as heartburn
  • has high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • takes a diuretic
  • has not been drinking fluids
  • has lost a lot of fluid due to vomiting or diarrhea
  • is a child with pain of arthritis
  • has asthma

Ask a doctor before use if

  • a stomach bleeding warning applies to user

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • users experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • has bloody or black stools
    • has stomach pain that does not get better
  • ringing in the ears or loss of hearing occurs
  • taking a prescription drug for diabetes, gout, or arthritis
  • adult's pain gets worse or lasts for more than 10 days
  • child's pain gets worse or lasts for more than 5 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present
  • new symptoms occur

If pregnant or breastfeeding,


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.

Keep out of reach of children.


In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • adults and children 12 years and over: two (2) caplets every 6 hours with a full glass of water with each dose. Do not exceed; adults 8 caplets and children 6 caplets in 24 hours .
  • children under 12 years of age: consult a doctor

Other Information

  • store between 68°-77°F (20°-25°C)
  • read all product information before using.
  • Keep box for important information.

Inactive Ingredients


corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions?


1-866-359-3478 (M-F) 9AM to 5PM EST or www.pharmadel.com

Distributed By / Distribuido Por:


PHARMADEL LLC

New Castle, DE, 19720

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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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