Indications and uses
temporarily relieves minor aches and pains due to: backache muscular aches headache the common cold toothache minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever
Pain Reliever
- Manufacturer
- Topco Associates, LLC | LNK International, Inc.
- Effective date
- 2019-04-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:25:22
Label at a glance#
ProductPain Reliever Extra Strength
Active ingredientACETAMINOPHEN
Label structure8 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) use by expiration date on package
Contacts and useful links#
Websitewww.topcarebrand.com
www.topcarebrand.com
www.topcarebrand.comLabel 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:
- backache
- muscular aches
- headache
- the common cold
- toothache
- minor pain of 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 in 24 hours, which is the maximum daily amount
- 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:
- blisters
- rash
- skin reddening
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
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
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- use by expiration date on package
Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Principal Display Panel
TopCare®
NDC 36800-531-06
EXTRA STRENGTH
Pain
Reliever
ACETAMINOPHEN
PAIN RELIEVER / FEVER REDUCER
• Easy to swallow
• Contains no aspirin
• Sweet coated
ACTUAL
SIZE
200 TABLETS - 500 mg EACH
COMPARE TO
EXTRA STRENGTH
TYLENOL®
active ingredient*
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
QUALITY GUARANTEED
DISTRIBUTED BY TOPCO ASSOCIATES LLC,
ELK GROVE VILLIAGE, IL 60007
©TOPCO LNK1216
QUESTIONS? 1-888-423-0139
topcare@topco.comwww.topcarebrand.com
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
50844 ORG081653106
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0036800495814 | GTIN-13: 0036800495814 EAN-13: 0036800495814 GTIN-12: 036800495814 UPC-A: 036800495814 GTIN storage (14 digits): 00036800495814 | topcare-44-531-reliever-1.jpg |
Products#
Every source-derived product name is available through these pages.
- Pain Reliever Extra Strength
- Acetaminophen
- FD&C YELLOW NO. 6
- FD&C RED NO. 40
- STARCH, CORN
- TITANIUM DIOXIDE
- POVIDONE
- D&C YELLOW NO. 10
- STEARIC ACID
- SUCRALOSE
- TALC
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-531 | 36800-531-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| 49cedc93-aa86-4003-be9e-ef340f263087 | 02c25cdd-f4fd-414e-9e79-dd70488fbb96 | 2019-04-24 | Warnings | 49cedc93-aa86-4003-be9e-ef340f263087 02c25cdd-f4fd-414e-9e79-dd70488fbb96 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.