Drug Facts "These highlights do not include all the information needed to use" "see full prescribing information for" "Initial U.S. Approval"
Active ingredient (in each tablet)
Acetaminophen 500mg
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains due to:
Temporarily reduces fever
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- menstrual cramps
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product
Do not use
- With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
OTC - STOP USE SECTION
Stop and ask doctor before use if:
Pain gets worse or lasts more than 10 days.
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregant or breast-feeding, ask doctor before use.
Keep out of reach of children.
Directions
- do not take more than directed (see overdose warning).
- Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
- Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.
Inactive ingredients
Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.
Questions?
Adverse drug event call: (866) 562-2756