FDA.reportPublic FDA data

Pharbetol

Manufacturer
Pharbest Pharmaceuticals, Inc.
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:49:13

Label at a glance#

ProductPharbetol Regular strength
Active ingredientACETAMINOPHEN
Label structure9 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 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directe by a doctor do not use for more than 10 days unless directed by a doctor children 6 to under 12 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg

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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.

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, which is the maximum daily amount
  • 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 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 if you have

OTC - ASK DOCTOR SECTION

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 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the 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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directe by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 16103-353-11

Manufactured in the USA

Regular Strength

*COMPARE TO the active ingredients in TYLENOL® REGULAR STRENGTH

Contains no Aspirin

PHARBETOL®

Acetaminophen 325 mg each

Pain Reliever • Fever Reducer

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

1000 TABETS

Pharbetol (Acetaminophen) 325 mg Tablet Product LabelPharbetol (Acetaminophen) 325 mg Tablet Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN5
1298830Pharbetol Regular Strength 325 MG Oral TabletPSN5
1298830acetaminophen 325 MG Oral Tablet [Pharbetol]SBD5
313782acetaminophen 325 MG Oral TabletSCD5
313782APAP 325 MG Oral TabletSY5
1298830APAP 325 MG Oral Tablet [Pharbetol]SY5
1298830Pharbetol 325 MG Oral TabletSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-353-072026-01-29C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-082026-01-29C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-112026-01-29C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-072023-06-13C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-082023-06-13C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-112023-06-13C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-072023-01-30C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-082023-01-30C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-112023-01-30C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-072021-01-08C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-082021-01-08C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-112021-01-08C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-072020-01-31C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-082020-01-31C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-112020-01-31C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-353-07PharbetolRegular strength60 in 1 BOTTLE, PLASTICTABLET605
16103-353-07PharbetolRegular strength1 in 1 CARTONTABLET15
16103-353-08PharbetolRegular strength100 in 1 BOTTLE, PLASTICTABLET1005
16103-353-08PharbetolRegular strength1 in 1 CARTONTABLET15
16103-353-11PharbetolRegular strength1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-353-07EA - Each16103-353be19f1cb-5a83-4ab8-a81c-dbc7b6c366b312013-05-02
16103-353-08EA - Each16103-353d0efd342-8f78-4b8b-b2ab-963c13f461bf12013-05-02
16103-353-11EA - Each16103-353239e09b4-a5bc-4312-a3cc-d82250536ba312013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
POVIDONESINACTIVE INGREDIENTFZ989GH94E1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6B1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

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
16103-35316103-353-07, 16103-353-08, 16103-353-11

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
ACETAMINOPHEN362O9ITL9DACTIB
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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
Pharbetol Regular strengthACETAMINOPHENPharbest Pharmaceuticals, Inc.e0a39957-d918-4125-88f9-0e550b976fa12025-12-24WarningsExact identifier
ndc (package): 16103-353-11
ndc (package): 16103-353-08
ndc (package): 16103-353-07
ndc (product): 16103-353
ndc11 (package): 16103035308
ndc11 (package): 16103035307
ndc11 (package): 16103035311
spl id: c23d82e7-ab4d-4bda-b63d-cc7f96bb79f6
spl set id: e0a39957-d918-4125-88f9-0e550b976fa1

Reported adverse events (FAERS/openFDA)#

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