Active Ingredient (In Each Gelcap)
Acetaminophen USP, 500 mg
The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc. for the product Acetaminophen (NDC 75907-433). 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 active ingredient (in each gelcap), purpose, uses, warnings:, allergy alert:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen USP, 500 mg
Pain reliever/fever reducer
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
liver disease
taking the blood thinning drug warfarin
These could be signs of a serious condition
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
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone k-30, pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide
call 1-888-375-3784weekdays 8:00 AM to 8:00 PM EST.
Distributed by:
Dr. Reddy’s Laboratories Inc.,
Princeton, NJ 08540
Made in India
REV: 06/26
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Extra Strength Tylenol® Rapid Release Gels. Tylenol® is a registered trademark of Kenvue Inc.
NDC 75907-433-52
Extra Strength
Acetaminophen
Gelcaps USP, 500 mg
Rapid Release
Pain Reliever / Fever Reducer
For Adults
225 Gelcaps
*Compare to the active ingredient in Extra Strength Tylenol ® Rapid Release Gels
* Please review the disclaimer below.