- 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 caplet)
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
FULL PRESCRIBING INFORMATION
Active ingredient (in each caplet)
Acetaminophen 650 mg
Pain reliever/fever reducer
•temporarily relieves minor aches and pains due to:
•minor pain of arthritis
•temporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
•more than 6 caplets 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.
•if you are allergic to acetaminophen or any of the inactive ingredients in this product
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.
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.
•do not take more than directed (see overdose warning)
adults and children 12 years and over
children under 12 years
•store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F).
•see end panel for lot number and expiration date
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide
Questions or comments?
Principal Display Panel
COMPARE TO the active ingredient of TYLENOL® 8 HR
See side panel
Extended-Release Tablets, 650 mg
Pain Reliever / Fever Reducer
For Up to 8 Hour Relief of Minor Muscle Aches and Pain
Headache/Backache/Minor Pain of Arthritis
100 CAPLETS* - 650 mg EACH
Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE