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 Cvs Pharmacy, Inc. for the product Acetaminophen (NDC 69842-635). 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 and children 12 years and over |
|
| children under 12 years |
|
colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin
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Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2023 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
Made in India
Code: TS/DRUGS/22/2009
CVS Health® Compare to the active ingredient in
Tylenol® 8HR Muscle Aches & Pain*
Tablets
NDC 69842-635-07
8HR Muscle Aches & Pain
ACETAMINOPHEN
EXTENDED-RELEASE TABLETS USP, 650 mg
Pain Reliever/Fever Reducer
For up to 8 hours of relief of minor
muscle aches & pain
Contains No Aspirin
24 EXTENDED-RELEASE
TABLETS 650 mg EACH
DO NOT USE WITH
OTHER MEDICINES
CONTAINING
ACETAMINOPHEN
* Please review the disclaimer below.