Active Ingredient (In Each Gelcap)
Acetaminophen 500 mg
The following Structured Product Label (SPL) was submitted to the FDA by Costco Wholesale Corporation for the product Acetaminophen (NDC 63981-019). 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 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
KIRKLAND
Signature
COMPARE TO
EXTRA STRENGTH TYLENOL®
RAPID RELEASE
active ingredient*
NDC 63981-019-05
ITM. / ART. 355476
EXTRA STRENGTH
ACETAMINOPHEN PM
GELCAPS. 500 mg
Pain Reliever/Fever Reducer
Temporarily Relieves:
• Headache
• Minor Pain of Arthritis
• Muscular Aches
• Backaches
Actual
Size
400
Gelcaps
500 mg EACH
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Johnson & Johnson Corporation,
owner of the registered trademark Extra Strength Tylenol® Rapid Release.
50844 REV0322Q51905
Manufactured by: LNK INTERNATIONAL, INC., 60 Arkay Drive, Hauppauge, NY 11788 USA 1-800-426-9391
Distributed by: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027 USA
www.costco.com 22V13038a
* Please review the disclaimer below.