Indications and uses
temporarily relieves minor aches and pains due to: headache toothache muscular aches backache the common cold minor pain from arthritis premenstrual and menstrual cramps temporarily reduces fever
TopCare 44-531
- Manufacturer
- Topco Associates, LLC | LNK International, Inc.
- Effective date
- 2026-08-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- daily-update
- Hydrated at
- 2026-08-18 02:02:59
Label at a glance#
ProductPain Relief
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets 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) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- muscular aches
- backache
- the common cold
- minor pain from arthritis
- 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
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
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 tablets every 6 hours while symptoms last
- do not take more than 6 tablets 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)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide
*may contain this ingredient
Questions or comments?
1-888-423-0139
Principal display panel
+TopCare®
health
NDC 36800-991-15
COMPARE TO THE
ACTIVE INGREDIENT IN
EXTRA STRENGTH TYLENOL®†
EXTRA STRENGTH
Pain Relief
ACETAMINOPHEN 500 mg
PAIN RELIEVER • FEVER REDUCER
Contains no aspirin • Coated tablets
50 TABLETS
actual size
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0036800115842 | GTIN-13: 0036800115842 EAN-13: 0036800115842 GTIN-12: 036800115842 UPC-A: 036800115842 GTIN storage (14 digits): 00036800115842 | topcare-44-531-1.jpg |
| QR code link | QR Code |  topbrnds.com/CSx9Ae | topcare-44-531-1.jpg |
Products#
Every source-derived product name is available through these pages.
- Pain Relief
- Acetaminophen
- STARCH, CORN
- D&C RED NO. 27 ALUMINUM LAKE
- D&C YELLOW NO. 10 ALUMINUM LAKE
- FD&C BLUE NO. 1 ALUMINUM LAKE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STEARIC ACID
- SUCRALOSE
- TALC
- TITANIUM DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-991 | 36800-991-15, 36800-991-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 11 | 2026-07-14 | daily-update | 2026-07-18 05:10:10 |
| 10 | 2025-07-09 | full-release | 2026-06-01 01:06:49 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pain Relief | ACETAMINOPHEN | Topco Associates, LLC | 8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101 | 2026-08-12 | Warnings | 36800-991-15 36800-991-06 36800-991 36800099106 36800099115 44608f7f-377f-4006-9c9e-d154e3a45e10 8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.