Acetaminophen Extended-Release Tablets, USP 650mg
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient (in each extended release tablet)
Acetaminophen USP 650 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- premenstrual and menstrual cramps
- the common cold
- headache
- toothache
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
- more than 6 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
whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before ue if you have liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- 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
Keep out of reach of children.
Overdose warning: 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).
Adults:
Under 18 years of age:
- take 2 tablets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 tablets in 24 hours
- do not use for more than 10 days unless directed by a doctor.
Other information
- store at 20º to 25ºC (68º to 77ºF). Avoid excessive heat 40ºC (104ºF)
- do not use if carton is opened or foil inner seal is broken
- USP Dissolution test is pending
Inactive ingredients
colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline
cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin