FDA.reportPublic FDA data

PHARBETOL

Manufacturer
A-S Medication Solutions
Effective date
2019-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:46

Label at a glance#

ProductPHARBETOL
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets, every 6 hours while symptoms last do not take more than 6 caplets 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

Tamper Evident: do not use if imprinted safety seal under cap is broken or missing store between 20 o -25 o C (68 o -77 o F)

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

  • more than 8 caplets 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

OTC - DO NOT USE SECTION

  • 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

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you have liver disease.

Ask a doctor or pharmacist before use if you are

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
  • 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Overdose warning:

OVERDOSAGE SECTION

In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)

    adults and children 12 years and over

    • take 2 caplets, every 6 hours while symptoms last
    • do not take more than 6 caplets 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

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20o-25oC (68o-77oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, talc, triacetin

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call: (866) 562-2756 Mon - Fri 8 AM to 4 PM

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1191

NDC: 50090-1191-0 40 TABLET, COATED in a BOTTLE

Acetaminophen 500mg

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
1293942Pharbetol 500 MG Oral TabletPSN1
1293942acetaminophen 500 MG Oral Tablet [Pharbetol]SBD1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1
1293942APAP 500 MG Oral Tablet [Pharbetol]SY1
1293942Pharbetol 500 MG Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1191-02023-01-30C16284748780-1f386c649-a5a6-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1191-0PHARBETOL40 in 1 BOTTLETABLET, COATED401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1191PHARBETOL (ACETAMINOPHEN 500MG) TABLET, COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190625_622b3838-9ecf-481d-bf4b-4ca0ffa77492.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1191-0EA - Each50090-119188379202-0159-4f74-99ec-3ea0d3191a1312019-07-02
16103-350-04EA - Each16103-350526744b9-dea5-417e-b300-418dedf58c0412019-04-11
16103-350-08EA - Each16103-350b5389dbb-d3cb-413e-b5e6-bf0eac6a6d0c12019-04-11
16103-350-10EA - Each16103-350fc23c7ec-3900-4d7f-9ada-9c394688f92c12022-06-06
16103-350-11EA - Each16103-3502d652227-a39c-44fe-abba-8910303a8c5912019-04-11

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-119150090-1191-0
16103-350

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TRIACETINXHX3C3X673IACT

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
PHARBETOLACETAMINOPHEN 500MGPharbest Pharmaceuticals, Inc.27337be9-e279-460e-903e-ae44630995992025-12-24WarningsExact identifier
ndc (product): 16103-350
8cd7dffe-2621-4b26-b679-4bb7ae028434622b3838-9ecf-481d-bf4b-4ca0ffa774922019-06-24WarningsExact identifier
spl id: 8cd7dffe-2621-4b26-b679-4bb7ae028434
spl set id: 622b3838-9ecf-481d-bf4b-4ca0ffa77492

Reported adverse events (FAERS/openFDA)#

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