Drug Facts
Active ingredient (in each extended-release tablet)
Acetaminophen USP 650 mg
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Acetaminophen (NDC 0363-9604). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each extended-release tablet)
Acetaminophen USP 650 mg
Pain reliever/fever reducer
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.
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
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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.
Adults:
Under 18 years of age:
colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin
Questions or comments?
1-855-274-4122
DISTRIBUTED BY: WALGREENS CO.
200 WILMOTRD., DEERFIELD, IL 60015
MADE IN INDIA
Code: TS/DRUGS/22/2009
Walgreens
NDC 0363-9604-07
TO OPEN: PUSH DOWN, TURN CAP
8 Hour
Arthritis Pain
Acetaminophen
Extended-Release
Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN
24
Extended-
release tablets
Walgreens
COMPARE TO the active ingredient of
TYLENOL® 8HR ARTHRITIS PAIN *See top panel
NDC 0363-9604-07
8 Hour
TO OPEN:
PUSH DOWN
TURN CAP
Arthritis Pain
Acetaminophen Extended-
Release Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN
actual size
24 Extended-
release tablets
* Please review the disclaimer below.