Active Ingredient (In Each Gelcap)
Acetaminophen 500 mg
Pain Relief Tablet, Coated
FDA Label NDC 36800-591
15 label sections · Submitted to the FDA by Topco Associates, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Pain Relief (NDC 36800-591). 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.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain from arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
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.
Directions
- do not take more than directed
- adults and children 12 years and over
- take 2 gelcaps every 6 hours while symptoms last
- do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: ask a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
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
Questions Or Comments?
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NDC 36800-591-12
COMPARE TO EXTRA STRENGTH
TYLENOL® RAPID RELEASE GELS
ACTIVE INGREDIENT*
EXTRA STRENGTH
Pain Relief
ACETAMINOPHEN 500 mg - PAIN RELIEVER • FEVER REDUCER
actual size
100 GELCAPS
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Kenvue Inc.,
owner of the registered trademark Extra Strength Tylenol®
Rapid Release Gels. 50844 REV0525C51912
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 © TOPCO LNKA0725
QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
Scan here for more
information or
call 1-888-423-0139
QUALITY GUARANTEED
This TopCare® product is laboratory
tested to guarantee its highest quality.
Your total satisfaction is guaranteed.
Topcare 44-519 (Topcare 44 519 1)
* Please review the disclaimer below.
