Acetaminophen 325 mg Tablets
SPL UNCLASSIFIED SECTION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Acetaminophen 325 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- common cold
- toothache
- premenstrual and menstrual cramps
- temporarily reduces fever.
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
- 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
OTC - DO NOT USE SECTION
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 you are allergic to acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the user has liver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.
OTC - STOP USE SECTION
Stop use and ask a doctor if
These could be signs of a serious condition.
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Directions
| adults and children 12 years and over | take 2 tablets every 4 to 6 hours while symptoms lastdo not take more than 10 tablets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctor |
| children 6 years to under 12 years | take 1 tablet every 4 to 6 hours, while symptoms lastdo not take more than 5 tablets in 24 hoursdo not use for more than 5 days unless directed by a doctor |
| children under 6 years | ask a doctor |
- do not take more than directed (see overdose warning)
STORAGE AND HANDLING SECTION
Other information
- store at room temperature in a dry place
INACTIVE INGREDIENT SECTION
Inactive ingredients
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
OTC - QUESTIONS SECTION
Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.
SPL UNCLASSIFIED SECTION
Distributed by: Plus Pharma, Commack, NY 11725
Manufactured in a GMP facility in the USA