FDA.reportPublic FDA data

Plus Pharma

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2022-01-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:47:18

Label at a glance#

ProductACETAMINOPHEN Pain Reliever,Fever Reducer
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pains due to: Headache Muscular aches Backache Minor pain of arthritis The common cold Toothache Premenstrual and menstrual cramps Temporarily reduces fever.

Dosage and administration

Do not take more than directed AGE DOSE Adults and Children 12 years and over Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours Children 6 - 11 years Take 1 tablet every 4 to 6 hours while symptoms last  Do not take more than 5 tablets in 24 hours Children under 6 years Do not use adult Regular Strength products in children under 6 years of age; this will provide mo...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen 
  • adult has 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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the user has

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if the user is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Pain gets worse or lasts more than 10 days in adults and children

Pain gets worse or lasts more than 5 days in children under 12 years

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Overdose warning:

OVERDOSAGE SECTION

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. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains due to:

  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • Premenstrual and menstrual cramps

Temporarily reduces fever.


Directions

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed

AGEDOSE
Adults and Children 12 years and over
  • Take 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 12 tablets in 24 hours
Children 6 - 11 years
  • Take 1 tablet every 4 to 6 hours while symptoms last
  •  Do not take more than 5 tablets in 24 hours
Children under 6 yearsDo not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

SPL UNCLASSIFIED SECTION


  • Do not use if imprinted Safety Seal under cap is broken or missing
  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

OTC - QUESTIONS SECTION

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel

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
68071-4118-22025-01-30C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-32025-01-30C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-42025-01-30C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-52025-01-30C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-62025-01-30C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-22020-08-19C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-32020-08-19C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-42020-08-19C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-52020-08-19C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-62020-08-19C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-22020-01-31C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-32020-01-31C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-42020-01-31C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-52020-01-31C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts
68071-4118-62020-01-31C16284748780-19d75b9cf-f0da-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4118-2ACETAMINOPHENPain Reliever,Fever Reducer20 in 1 BOTTLETABLET204
68071-4118-3ACETAMINOPHENPain Reliever,Fever Reducer30 in 1 BOTTLETABLET304
68071-4118-4ACETAMINOPHENPain Reliever,Fever Reducer40 in 1 BOTTLETABLET404
68071-4118-5ACETAMINOPHENPain Reliever,Fever Reducer25 in 1 BOTTLETABLET254
68071-4118-6ACETAMINOPHENPain Reliever,Fever Reducer60 in 1 BOTTLETABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4118ACETAMINOPHEN PAIN RELIEVER,FEVER REDUCER (ACETAMINOPHEN) TABLET [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC, 5 package rows20220121_5b6f4839-1f2b-94b2-e053-2a91aa0a85e0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51645-703-01EA - Each51645-7031c8a57e7-e5ec-4f20-9653-a270349a753212021-11-09

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
68071-411868071-4118-2, 68071-4118-5, 68071-4118-3, 68071-4118-4, 68071-4118-6
51645-703

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
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d6070f38-515c-049e-e053-2a95a90aade65b6f4839-1f2b-94b2-e053-2a91aa0a85e02022-01-20WarningsExact identifier
spl id: d6070f38-515c-049e-e053-2a95a90aade6
spl set id: 5b6f4839-1f2b-94b2-e053-2a91aa0a85e0

Reported adverse events (FAERS/openFDA)#

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