FDA.reportPublic FDA data

Acetaminophen

Manufacturer
Physicians Total Care, Inc.
Effective date
2012-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:47

Label at a glance#

ProductAcetaminophen Extra Strength
Active ingredientAcetaminophen
Label structure8 sections

Indications and uses

temporarily relieves minor aches and pains temporarily reduces fever

Dosage and administration

do not take more than directed adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours children under 12 years: do not use

Storage and handling

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store at 20⁰C-25⁰C (68⁰F-77⁰F) for institutional use only

Label contents#

Full prescribing information#

Active Ingredients

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
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 8 tablets 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

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
  • new symptom 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.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
  • children under 12 years: do not use

Other Information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • for institutional use only

Inactive Ingredients

INACTIVE INGREDIENT SECTION

povidone, sodium starch glycolate, starch stearic acid. May also contain: crospovidone, methylparaben and probylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54868-2457-2

image of package labelimage of package label

SEE NEW WARNINGS

Non-Aspirin

Extra Strength

PAIN RELIEF

Acetaminophen Tablets

*Compare to active ingredient in Extra Strength Tylenol Tablets

PACKAGE NOT CHILD RESISTANT

500 mg each

Dist. By: Gericare Pharmaceuticals Corp.

1650 63rd Street, Brooklyn, NY 11204


Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146



DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-2457-22019-09-24C16284748780-19350213a-436d-c013-e053-90daa90a139333376625-3cc2-4bf2-9009-a3e728f4b8f5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-2457-2AcetaminophenExtra Strength100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-2457ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]11 package rows20120130_33376625-3cc2-4bf2-9009-a3e728f4b8f5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-201-01EA - Each57896-20182dbdfae-7cce-45e7-bf0c-c214686bb89612012-07-24
57896-201-05EA - Each57896-2015d0770cd-70c2-4757-896d-62e868f751c012022-06-06
57896-201-10EA - Each57896-201aa5f4c60-e670-45f2-861b-c2ad8e686e2a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
AcetaminophenACTIVE MOIETY362O9ITL9D1
CROSPOVIDONEINACTIVE INGREDIENT68401960MK1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A21
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54868-245754868-2457-2
57896-201

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
CROSPOVIDONE68401960MKIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii+route+dosage form
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii+route+dosage form
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp7570aaa2-3238-4cd3-b788-915caa970dba2025-12-04WarningsExact identifier
ndc (product): 57896-201
902526fc-a17b-481a-98bd-fe9f63a7742d33376625-3cc2-4bf2-9009-a3e728f4b8f52012-01-24WarningsExact identifier
spl id: 902526fc-a17b-481a-98bd-fe9f63a7742d
spl set id: 33376625-3cc2-4bf2-9009-a3e728f4b8f5

Reported adverse events (FAERS/openFDA)#

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