Acetaminophen

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2023-09-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:56:13

Label at a glance#

ProductAcetaminophen
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 2 tablets every 4-6 hours, as needed; not more than 10 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 325 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 4,000 mg (12 tablets) 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 2 tablets every 4-6 hours,
    as needed; not more than 10 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.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN3
313782acetaminophen 325 MG Oral TabletSCD3
313782APAP 325 MG Oral TabletSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2481-22025-01-30C16284748780-12cef2736-6f9a-d83d-e063-dadaa90ab31fgc101 (104)
68071-2481-32025-01-30C16284748780-12cef2736-6f9a-d83d-e063-dadaa90ab31fgc101 (104)
68071-2481-42025-01-30C16284748780-12cef2736-6f9a-d83d-e063-dadaa90ab31fgc101 (104)
68071-2481-52025-01-30C16284748780-12cef2736-6f9a-d83d-e063-dadaa90ab31fgc101 (104)
68071-2481-72025-01-30C16284748780-12cef2736-6f9a-d83d-e063-dadaa90ab31fgc101 (104)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2481-2Acetaminophen20 in 1 BOTTLETABLET203
68071-2481-3Acetaminophen30 in 1 BOTTLETABLET303
68071-2481-4Acetaminophen40 in 1 BOTTLETABLET403
68071-2481-5Acetaminophen50 in 1 BOTTLETABLET503
68071-2481-7Acetaminophen25 in 1 BOTTLETABLET253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2481ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 5 package rows20230920_c7cc3f87-3fbe-430a-e053-2a95a90a4e79.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-104-01EA - Each57896-1049c729477-9f92-45a4-9237-ba204105dab912023-06-06
57896-104-10EA - Each57896-104912af808-5ba7-4a40-9353-9a868e25569d12021-05-05
57896-104-20EA - Each57896-104cd916e63-66db-4bb5-97b2-9c366aee75d612021-11-09

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
68071-248168071-2481-5, 68071-2481-4, 68071-2481-3, 68071-2481-2, 68071-2481-7
57896-104

Ingredients#

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

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
05bd9ef2-fe59-08b4-e063-6394a90a58bac7cc3f87-3fbe-430a-e053-2a95a90a4e792023-09-19WarningsExact identifier
spl id: 05bd9ef2-fe59-08b4-e063-6394a90a58ba
spl set id: c7cc3f87-3fbe-430a-e053-2a95a90a4e79

Reported adverse events (FAERS/openFDA)#

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