FDA.reportPublic FDA data

Acetaminophen 500 mg Tablet

Manufacturer
A-S Medication Solutions
Effective date
2021-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:41

Label at a glance#

ProductPlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg
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 500 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
  • the 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 you take

  • more than 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.

OTC - DO NOT USE SECTION

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.
  • 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 you have liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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
  • 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: 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 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor.
  • children under 12 years: ask 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: 50090-5548

NDC: 50090-5548-4 24 TABLET in a BOTTLE

NDC: 50090-5548-1 30 TABLET in a BOTTLE

NDC: 50090-5548-2 100 TABLET in a BOTTLE, PLASTIC

PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG (ACETAMINOPHEN) TABLET

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

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
50090-5548-12023-01-30C16284748780-1f386c649-b9fb-0266-e053-dadaa90a7c1aAcetaminophen 500 mg Tablet
50090-5548-22023-01-30C16284748780-1f386c649-b9fb-0266-e053-dadaa90a7c1aAcetaminophen 500 mg Tablet
50090-5548-42023-01-30C16284748780-1f386c649-b9fb-0266-e053-dadaa90a7c1aAcetaminophen 500 mg Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5548-1PlusPharma Extra StrengthPAIN RELIEVER,FEVER REDUCER 500 mg30 in 1 BOTTLETABLET301
50090-5548-2PlusPharma Extra StrengthPAIN RELIEVER,FEVER REDUCER 500 mg100 in 1 BOTTLE, PLASTICTABLET1001
50090-5548-4PlusPharma Extra StrengthPAIN RELIEVER,FEVER REDUCER 500 mg24 in 1 BOTTLETABLET241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5548PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG (ACETAMINOPHEN) TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 3 package rows20210603_6d95bc86-665c-49cf-accc-5a09ae7732e1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51645-706-01EA - Each51645-7069d69e3fa-cc3b-4b62-a473-63c1e4b8d08912022-10-06
51645-706-10EA - Each51645-7061ecd9f01-bdc1-4496-908c-9774c760dfd912021-11-09

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
50090-554850090-5548-4, 50090-5548-1, 50090-5548-2
51645-706

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
32651592-e9f4-4b03-b701-b9e52882a8376d95bc86-665c-49cf-accc-5a09ae7732e12021-06-02WarningsExact identifier
spl id: 32651592-e9f4-4b03-b701-b9e52882a837
spl set id: 6d95bc86-665c-49cf-accc-5a09ae7732e1

Reported adverse events (FAERS/openFDA)#

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