Active Ingredient (In Each Gelcap)
Acetaminophen 500 mg
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Acetaminophen (NDC 0536-1292). 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, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 500 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.
liver disease.
taking the blood thinning drug warfarin.
These could be signs of a serious condition
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide
1-800-645-2158
Rugby
NDC 0536-1292-29
Compare to the active ingredient in Extra Strength Tylenol® Rapid Release Gels*
Extra Strength
Acetaminophen
500 mg
Pain Reliever / Fever Reducer
Rapid Release Gelcaps
Does not contain any Aspirin
Actual Size
100 Gelcaps
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Rev. 05/20 R-17 Re-order No. 371026
Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
www.rugbylaboratories.com
*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Extra Strength Tylenol®
Rapid Release Gels. 50844 ORG041751912
* Please review the disclaimer below.