Active Ingredient (In Each Gelcap)
Acetaminophen 500 mg
The following Structured Product Label (SPL) was submitted to the FDA by L.n.k. International, Inc. for the product Pain Reliever (NDC 50844-519). 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. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
liver disease.
taking the blood thinning drug warfarin.
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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
Call 1-800-426-9391
QUALITY PLUS NDC 50844-519-02
*Compare to the active ingredient in Extra Strength TYLENOL® Rapid Release Gels
EXTRA STRENGTH
Pain Reliever
Acetaminophen 500 mg
PAIN RELIEVER/FEVER REDUCER
NON-ASPIRIN
12 Rapid Release Gelcaps Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength TYLENOL® Rapid Release Gels.
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA 50844 REV0513C51902
* Please review the disclaimer below.