- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredient (in each gelcap)
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
FULL PRESCRIBING INFORMATION
Active ingredient (in each gelcap)
Acetaminophen 500 mg
Pain reliever/fever reducer
•temporarily relieves minor aches and pains due to:
•minor pain of arthritis
•the common cold
•premenstrual and menstrual cramps
•temporarily reduces fever
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. Severe liver damage may occur if you take
•more than 4,000 mg of acetaminophen in 24 hours
•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.
•if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
Stop use and ask a doctor 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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
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.
•do not take more than directed (see Liver warning)
adults and children 12 years and over
children under 12 years
ask a doctor
•store at 20°-25°C (68°-77°F)
colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide
Questions or comments?
Principal Display Panel
COMPARE TO the active ingredient of TYLENOL® EXTRA STRENGTH RAPID RELEASE GELS
See side panel
Pain Reliever / Fever Reducer
500 mg EACH
Acetaminophen TABLET, COATED