FDA.reportPublic FDA data

Pharbetol

Manufacturer
Ulai Health LLC
Effective date
2025-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:18

Label at a glance#

ProductPharbetol
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 directed 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 u...

Storage and handling

store at 20-25 0 C (68-77 0 F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

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 a 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
  • redness or swelling is present
  • new symptoms occur

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: In 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 directed 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 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25 0C (68-77 0F)

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 73057-353-11

Manufactured in the USA

Regular Strength *COMPARE TO the active ingredient in TYLENOL ® Regular Strength

Contains no Aspirin

PHARBETOL

Acetaminophen 325 mg each

Pain Reliever/Fever Reducer

1000 TABLETS

Ulai Pharbetol 325 mg Tablet 1000 ct. LabelUlai Pharbetol 325 mg Tablet 1000 ct. Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN3
1298830Pharbetol Regular Strength 325 MG Oral TabletPSN3
1298830acetaminophen 325 MG Oral Tablet [Pharbetol]SBD3
313782acetaminophen 325 MG Oral TabletSCD3
313782APAP 325 MG Oral TabletSY3
1298830APAP 325 MG Oral Tablet [Pharbetol]SY3
1298830Pharbetol 325 MG Oral TabletSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73057-353-082022-01-31C16284748780-1d6a99b39-9ed0-a426-e053-dadaa90af4c2Drug Facts
73057-353-112022-01-31C16284748780-1d6a99b39-9ed0-a426-e053-dadaa90af4c2Drug Facts
73057-353-082022-01-28C16284748780-1d6a99b39-9ed0-a426-e053-dadaa90af4c2Drug Facts
73057-353-112022-01-28C16284748780-1d6a99b39-9ed0-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-353-08Pharbetol100 in 1 BOTTLE, PLASTICTABLET1003
73057-353-11Pharbetol1000 in 1 BOTTLE, PLASTICTABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-353PHARBETOL (ACETAMINOPHEN 325 MG) TABLET [ULAI HEALTH LLC]3Current NDC, Legacy NDC, 2 package rows20250122_55bb7e6c-e98c-48bd-b7bb-9848ff0273ca.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73057-35373057-353-11, 73057-353-08

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
PharbetolACETAMINOPHEN 325 MGUlai Health LLC55bb7e6c-e98c-48bd-b7bb-9848ff0273ca2025-01-20WarningsExact identifier
ndc (package): 73057-353-08
ndc (package): 73057-353-11
ndc (product): 73057-353
ndc11 (package): 73057035308
ndc11 (package): 73057035311
spl id: 2c278315-923c-873b-e063-6394a90afc61
spl set id: 55bb7e6c-e98c-48bd-b7bb-9848ff0273ca

Reported adverse events (FAERS/openFDA)#

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