ACETAMINOPHEN- acetaminophen tablet
Akron Pharma Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active ingredient (in each tablet)
Acetaminophen 325 mg
Purpose
Pain Reliever/Fever Reducer
Uses
To reduce fever and for the temporary relief of minor aches and pains due to:
- •
- headache
- •
- muscular aches
- •
- backache
- •
- minor pain of arthritis
- •
- the common cold
- •
- toothache
- •
- premenstrual and menstrual cramps.
Temporarily reduces fever.
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if the user has ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if the user has
- has liver disease
- is a child with pain of arthritis
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
Stop use and ask a doctor if:
- pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions - do not take more than directed (see overdose warning)
Do not take more then directed (see overdose warning)
adults & 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 use for more than 10 days unless directed by a doctor
|
Children 6 to 11 years |
- take one tablet every 4 to 6 hourswhile sysmtoms last
- do not take more than 5 tablets in 24 hours
- do not use for more than 5 days unless directed by a doctor
|
child under 6 years | ask a doctor |
Other information
- store at temperature 15° to 30°C (59° to 86°F)
Inactive Ingredients:
pregelatinized starch, microcrystalline cellulose, povidone, colloidal silicon dioxide, croscarmellose sodium, stearic acid
Questions or Comments?
Call toll-free 1-877-225-6999
Manufactured for
Akron Pharma, Inc.,
373 RT US46 W Building E,
Suite 117, Fairfeld, NJ - 07004
*This product is not manufactured or distributed by McNeil Consumer Inc., distributor of Regular Strength Tylenol Tablets.
Akron Pharma Inc.