FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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-Do not use:
• if you are allergic to aspirin or any other salicylate
• if you have ever had an allergic reaction to any other pain
reliever/fever reducer
Liver Warning: This product contains acetaminophen. Severe liver damage
may occur if you take:
• more than 8 tablets in 24 hours
• with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
• 3 or more alcoholic drinks every day while using this product
Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause stomach bleeding. The chance is 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 an NSAID (aspirin, ibuprofen, naproxen, or others.
• Take more or for a longer time than directed
Do not use:
• with any other pain reliever/fever reducer
• for pain for more than 10 days or for fever for more than 3
days unless directed by a doctor
• with any other product containing acetaminophen
Ask doctor before using if you have:
• upset stomach or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or older
Ask a doctor or pharmacist before use if you are:
• taking any other drug containing an NSAID (prescription or
nonprescription)
• taking a blood thinning (anticoagulant) or steroid drug
When using this product do not exceed recommended dose
Stop use and ask a doctor if:
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Uses: temporarily relieves minor aches and pains associated with:
• common cold
• headache
• muscular aches
• pre menstrual and menstrual cramps
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Pain Stoppers Regular Manufacturers
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North Safety Products Llc
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