- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
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FULL PRESCRIBING INFORMATION: CONTENTS*
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FULL PRESCRIBING INFORMATION
Pain Reliever, pain reliever aid
Temporarily relieves minor aches and pains due to:
- a cold
- muscular aches
- premenstrual and menstrual cramps
Reye's syndrome : Children and teenagers who have or are recovering for 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 include:
- facial swelling
- asthma (wheezing)
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 using this product
- more or for a longer time than directed
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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 beverage while taking this product because too much caffeine may cause nervousness, irritability, sleepleness, and, occasionally, rapid heartbeat.
Do Not Use
- if you 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 drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
- you have liver disease
- the 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 have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are taking
- any other drug containing an NSAID (prescription or nonprescription)
- a blood thinning (anticoagulant) or steroid drug
- a prescription drug for diabetes, gout or arthritis
- any other drug, or are under a doctor’s care for any serious condition
Stop Use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or loss of hearing occurs
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever get worse or lasts for more than 3 days
- any new symptoms appear
If pregnant or breast-feeding,
Ask a health professional before use.
Keep Out of Reach of Children
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not use more than directed
- drink a full glass of water in each dose
- adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours
- children under 12 years: ask a doctor
- store at room temperature 20-25°C (68°-77°F)
- Read all product information before using.
- do not use if imprinted safety seal under cap is broken or missing
- You may report serious side effects to 1-888-952-0050
corn starch, croscarmellose sodium, crospovidone, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide*. *May contain these ingredients.
QUESTIONS OR COMMENTS?
Call toll free 1 877 99 GENOM (43666)
PRINCIPAL DISPLAY PANEL
Acetaminophen and Aspirin and Caffeine TABLET