FDA.reportPublic FDA data

Acetaminophen 325 mg Tablets

Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2023-11-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:21:31

Label at a glance#

ProductPlus Pharma Pain Reliever,Fever Reducer
Active ingredientACETAMINOPHEN
Label structure12 sections

Storage and handling

Other information store at room temperature in a dry place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 325 mg

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever.

WARNINGS SECTION

Warnings

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • 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.

OTC - DO NOT USE SECTION

Do not use

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user has liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • 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.

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. (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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
  • take 1 tablet every 4 to 6 hours, while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 yearsask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature in a dry place

INACTIVE INGREDIENT SECTION

Inactive ingredients

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by: Plus Pharma, Commack, NY 11725

Manufactured in a GMP facility in the USA

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 53002-4600

NDC: 53002-4600-2 20 TABLET in a BOTTLE

NDC: 53002-4600-3 30 TABLET in a BOTTLE

Acetaminophen 325mg Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-4600-22023-11-08C16284748780-19d75b9d0-f9c7-f424-e053-dadaa90a57ceAcetaminophen 325 mg Tablets
53002-4600-32023-11-08C16284748780-19d75b9d0-f9c7-f424-e053-dadaa90a57ceAcetaminophen 325 mg Tablets
53002-4600-22023-01-30C16284748780-19d75b9d0-f9c7-f424-e053-dadaa90a57ceAcetaminophen 325 mg Tablets
53002-4600-32023-01-30C16284748780-19d75b9d0-f9c7-f424-e053-dadaa90a57ceAcetaminophen 325 mg Tablets
53002-4600-22020-12-17C16284748780-19d75b9d0-f9c7-f424-e053-dadaa90a57ceAcetaminophen 325 mg Tablets
53002-4600-32020-12-17C16284748780-19d75b9d0-f9c7-f424-e053-dadaa90a57ceAcetaminophen 325 mg Tablets
53002-4600-22020-01-31C16284748780-19d75b9d0-f9c7-f424-e053-dadaa90a57ceAcetaminophen 325 mg Tablets
53002-4600-32020-01-31C16284748780-19d75b9d0-f9c7-f424-e053-dadaa90a57ceAcetaminophen 325 mg Tablets

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
53002-460053002-4600-2, 53002-4600-3
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
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
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
93402e2a-14e0-4473-9f43-fe2f28a97eb7e8fe2124-50d0-4307-8b4e-75edda6a96c32023-11-07WarningsExact identifier
spl id: 93402e2a-14e0-4473-9f43-fe2f28a97eb7
spl set id: e8fe2124-50d0-4307-8b4e-75edda6a96c3

Reported adverse events (FAERS/openFDA)#

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