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 directedCaffeine warning: The recommended dose of this product contains about as much caffeine as a
cup of coffee.
When using this product:
limit the use of caffeine containing medications, food or beverages, too much caffeine may cause nervousness,sleeplessness,irritability,occasionally, rapid heartbeat
Do not use:
If you ever had an allergic reaction to any other pain reliever/fever reducer
• 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 If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist
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
with any other drug containing an NSAID (prescription or nonprescription). Ask a doctor before using
with other drugs if you are not sure
• 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
for the temporary relief of minor aches and pain with a headache
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 Extra Manufacturers
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North Safety Products Llc
Pain Stoppers Extra | North Safety Products Llc
Do not take more than directed
the smallest effective dose should be used
adults and children 12 years of age and over; take 2 tablets with a full glass of water every 4 hours
do not take more than 16 tablets in 24 hours
do not take longer than 10 days, unless directed by a doctor
children under 12 years: ask a doctor
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