FDA.reportPublic FDA data

Pain Relief

Manufacturer
Topco Associates, LLC | LNK International, Inc.
Effective date
2026-02-10
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:43:49

Label at a glance#

ProductPain Relief
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and 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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each gelcap)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

+TopCare®
          health

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
topcare@topco.com 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN12
198440acetaminophen 500 MG Oral TabletSCD12
198440APAP 500 MG Oral TabletSY12

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800199910GTIN-13: 0036800199910
EAN-13: 0036800199910
GTIN-12: 036800199910
UPC-A: 036800199910
GTIN storage (14 digits): 00036800199910		topcare-44-519-1.jpg
QR code linkQR Codetopbrnds.com/ExvrbUtopcare-44-519-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
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20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
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20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
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00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-591-05Pain Relief400 in 1 BOTTLE, PLASTICTABLET, COATED40012
36800-591-08Pain Relief1 in 1 CARTONTABLET, COATED112
36800-591-08Pain Relief24 in 1 BOTTLE, PLASTICTABLET, COATED2412
36800-591-12Pain Relief1 in 1 CARTONTABLET, COATED112
36800-591-12Pain Relief100 in 1 BOTTLE, PLASTICTABLET, COATED10012
36800-591-20Pain Relief1 in 1 CARTONTABLET, COATED112
36800-591-20Pain Relief225 in 1 BOTTLE, PLASTICTABLET, COATED22512

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-59136800-591-08, 36800-591-12, 36800-591-20, 36800-591-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReliefACETAMINOPHENTopco Associates, LLC2e31fe65-5f50-455b-99fa-c72879f435452026-02-10WarningsExact identifier
ndc (package): 36800-591-12
ndc (package): 36800-591-05
ndc (package): 36800-591-08
ndc (package): 36800-591-20
ndc (product): 36800-591
ndc11 (package): 36800059108
ndc11 (package): 36800059120
ndc11 (package): 36800059105
ndc11 (package): 36800059112
spl id: 2fef8293-e904-4b4a-a16a-8379d3dd1c14
spl set id: 2e31fe65-5f50-455b-99fa-c72879f43545

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.