FDA.reportPublic FDA data

Acetaminophen

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2022-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:32

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure9 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 6 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor. children under 12 years: ask a doctor

Storage and handling

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

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 (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
  • 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..

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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
  • adults and children 12 years and over: Take 1-2 tablets every 4-6 hours, as needed; not more than 6 tablets in 24 hours. 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

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

povidone, sodium starch glycolate, starch, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2821-22025-01-30C16284748780-12cef2736-5fa2-d83d-e063-dadaa90ab31fgc204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2821-2Acetaminophen20 in 1 BOTTLETABLET201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2821ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220827_e72bf35b-acc9-3562-e053-2995a90aeff3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-204-01EA - Each57896-2045b5981d9-4c39-4d62-9bb3-1944ee83a12812018-12-13
57896-204-05EA - Each57896-2040ef19d63-6981-46b8-a80e-e204eb7dc37012021-06-02
57896-204-20EA - Each57896-204a4fc79ba-8933-4ac1-9056-046d8a6d1c3b12022-03-09

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
68071-282168071-2821-2
57896-204

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
STARCH, CORNO8232NY3SJIACT
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a29dde6-a177-6206-e053-2991aa0a01f22025-12-04WarningsExact identifier
ndc (product): 57896-204
e72bf35b-acca-3562-e053-2995a90aeff3e72bf35b-acc9-3562-e053-2995a90aeff32022-08-26WarningsExact identifier
spl id: e72bf35b-acca-3562-e053-2995a90aeff3
spl set id: e72bf35b-acc9-3562-e053-2995a90aeff3

Reported adverse events (FAERS/openFDA)#

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