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 Aurohealth Llc for the product Acetaminophen (NDC 58602-848). 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?
call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
Made in India
Code: TS/DRUGS/22/2009
HealthyLiving
TO OPEN: 1. PUSH DOWN NDC 58602-848-21
2. TURN CAP
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
8 HOUR ARTHRITIS PAIN
Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
100 Extended-release tablets
HealthyLiving
NDC 58602-848-21
*Compare to the Active
Ingredient in Tylenol®
8 HR Arthritis Pain
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
8 HOUR ARTHRITIS PAIN
Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
100 Extended-release tablets
* Please review the disclaimer below.