FDA.reportPublic FDA data

Acetaminophen Tablet

Manufacturer
Keltman Pharmaceuticals Inc.
Effective date
2011-03-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:27:32

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure12 sections

Indications and uses

temporarily relieves minor aches and pains temporarily relieves reduces fever

Dosage and administration

Do not take more than directed Age Dose Adults and Children 12 years and over Take 1-2 tablets every 4-6 hours, as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years Do not use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

*Compared to the active ingredient in Extra-Strength Tylenol® Tablets

Drug Facts

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Acetaminophen 500 mg

PURPOSES

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

USES

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains
  • temporarily relieves 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 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.

OVERDOSAGE

OVERDOSAGE SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed

AgeDose
Adults and Children 12
years and over		Take 1-2 tablets every 4-6 hours, as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 yearsDo not use.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.

  • store at 20°-25°C (68°-77°F)
  • for institutional use only

INACTIVE INGREDIETNS:

INACTIVE INGREDIENT SECTION

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

Distributor Information:

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®.

Distributed by: GERI-CARE PHARMACEUTICALS CORP. 1650 63rd St., Brooklyn, New York 11204

This Product was Repackaged By Sandhills Packaging For:

Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, MS 39232
United States

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
198440acetaminophen 500 MG Oral TabletSCD2
198440APAP 500 MG Oral TabletSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68387-214-302019-10-29C16284748780-1960f7f55-d9ee-8e05-e053-dbdaa90a074aAcetaminophen Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-214-30ACETAMINOPHEN30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-214ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]2Legacy NDC, 1 package rows20110324_39580eb4-50dd-4381-a00f-359c68ce1cb4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-214-30EA - Each68387-214ef3fe253-8d28-474d-a78c-91d7ce42ceef12012-07-24
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 INGREDIENT362O9ITL9D2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
POVIDONEINACTIVE INGREDIENTFZ989GH94E2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A22
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68387-21468387-214-30
57896-201

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

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 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 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
847dce67-5308-4ef6-acb4-e8f54959c74339580eb4-50dd-4381-a00f-359c68ce1cb42011-03-21WarningsExact identifier
spl id: 847dce67-5308-4ef6-acb4-e8f54959c743
spl set id: 39580eb4-50dd-4381-a00f-359c68ce1cb4

Reported adverse events (FAERS/openFDA)#

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