FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
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.
Liver Warning:
This product contains Acetaminophen. Severe liver damage may occur if:
•
you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription
or non-prescription)
• you have 3 or more alcoholic drinks every day while using this product
Stomach Bleeding Warning:
This product contains nonsteroidal anti-inflammatory drugs (NSAIDs)
which may cause stomach bleeding. The chance is higher if you:
• have had stomach ulcers or bleeding
problems
• take a blood thinning (anticoagulant) or steroid drug • are age 60 or older • have 3 or more
alcoholic drinks every day while using this product
• take with other drugs containing an NSAID • you take more
or for a longer time than directed
Do not use:
• if you are allergic to aspirin • with any other pain reliever/fever reducer • if you have ever had an
allergic reaction to 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:
• asthma • stomach problems (such as heartburn, upset stomach or
stomach pain)
• gastric ulcers • bleeding problems
Ask a doctor or pharmacist before use if
you are taking a prescription drug for:
•anticoagulation (thinning of blood) • diabetes • gout • arthritis
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
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:
• headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Pain Reliever Manufacturers
- Advanced First Aid, Inc.
- Ca-botana International
- Hannaford Brothers Company
Pain Reliever | Hannaford Brothers Company
do not take more than directed (see Liver warning) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 12 tablets in 24 hourschildren
6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hourschildren under
6 years do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage - Walgreen Company
Pain Reliever | Walgreen Company
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 8 hours with water swallow whole – do not crush, chew or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor children under 12 years do not use - Hannaford Brothers Company
Pain Reliever | Hannaford Brothers Company
do not take more than directed (see Liver warning) adults and children 12 years and over - Stephen L. Lafrance Pharmacy, Inc.
Pain Reliever | Stephen L. Lafrance Pharmacy, Inc.
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not take for more than 10 days unless directed by a doctor children 6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not take for more than 5 days unless directed by a doctor children under 6 years: ask a doctor - Stephen L. Lafrance Pharmacy, Inc.
Pain Reliever | L&r Distributors, Inc.
do not take more than directed
adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor - Nash-finch Company
Pain Reliever | Nash-finch Company
do not take more than directed
(see overdose warning) adults and children 12 years and over take 2 caplets every 4 to 6 hours while symptoms last do not take more than 8 caplets in 24 hours do not take for more than 10 days unless directed by a doctor children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
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