FDA.reportPublic FDA data

Regular Strength Pain Relief

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:13:38

Label at a glance#

ProductRegular Strength Pain Relief
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 children under 12 years: ask a doctor

Storage and handling

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.
The maximum daily dose of this product is 10 tablets
in 24 hours. Severe liver damage may occur if you take:

  • more than 12 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 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • 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 TabletPSN4
313782acetaminophen 325 MG Oral TabletSCD4
313782APAP 325 MG Oral TabletSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4656-52024-06-13C16284748780-1ba0f9c33-0cf4-a910-e053-dadaa90a0b85gc 102
68071-4656-52023-01-30C16284748780-1ba0f9c33-0cf4-a910-e053-dadaa90a0b85gc 102
68071-4656-52021-02-17C16284748780-1ba0f9c33-0cf4-a910-e053-dadaa90a0b85gc 102
68071-4656-52021-01-29C16284748780-1ba0f9c33-0cf4-a910-e053-dadaa90a0b85gc 102

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4656-5Regular Strength Pain Relief50 in 1 BOTTLETABLET504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4656REGULAR STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240615_7c73fc75-af9b-177c-e053-2a91aa0ada56.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-102-01EA - Each57896-1024fd0e2b7-fd19-4784-9e24-f0fc69b7491012019-01-24
57896-102-05EA - Each57896-102b63010e7-a608-44c2-b043-44d6f2818c5912019-02-13
57896-102-10EA - Each57896-1026b3d573d-baa1-4daf-aba9-717aa1dcfc7412019-02-13
57896-102-20EA - Each57896-10240b6eab0-c1a1-4c63-82f8-78251de158a212021-12-08

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-465668071-4656-5
57896-102

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
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STARCH, CORNO8232NY3SJIACT

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
Regular Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp6158e954-32d8-4718-e053-2a91aa0a27f32024-12-31WarningsExact identifier
ndc (product): 57896-102
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.7c73fc75-af9b-177c-e053-2a91aa0ada562024-06-12WarningsExact identifier
ndc (package): 68071-4656-5
ndc (product): 68071-4656
ndc11 (package): 68071465605
spl id: 1ab856e2-c792-0d29-e063-6294a90a025b
spl set id: 7c73fc75-af9b-177c-e053-2a91aa0ada56

Reported adverse events (FAERS/openFDA)#

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