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 00:53:20

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 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact(866) 562-2756

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 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. 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.

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
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 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Other information

OTHER SAFETY INFORMATION

store at 20-25 ⁰C (68-77 ⁰F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 73057-350-11

Manufactured in the USA

Extra Strength *Compare to the active ingredient in Extra Strength Tylenol ^® Caplet

Contains no Aspirin

PHARBETOL

Acetaminophen 500 mg each

Pain Reliever/Fever Reducer

1000 CAPLETS

Ulai Pharbetol 500 mg Caplet 1000 ct. Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	3
1293942	Pharbetol 500 MG Oral Tablet	PSN	3
1293942	acetaminophen 500 MG Oral Tablet [Pharbetol]	SBD	3
198440	acetaminophen 500 MG Oral Tablet	SCD	3
198440	APAP 500 MG Oral Tablet	SY	3
1293942	APAP 500 MG Oral Tablet [Pharbetol]	SY	3
1293942	Pharbetol 500 MG Oral Tablet	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73057-350-08	2022-01-31	C162847	48780-1	d6a99b39-9ea0-a426-e053-dadaa90af4c2	Drug Facts
73057-350-11	2022-01-31	C162847	48780-1	d6a99b39-9ea0-a426-e053-dadaa90af4c2	Drug Facts
73057-350-08	2022-01-28	C162847	48780-1	d6a99b39-9ea0-a426-e053-dadaa90af4c2	Drug Facts
73057-350-11	2022-01-28	C162847	48780-1	d6a99b39-9ea0-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73057-350-08	Pharbetol	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100		3
73057-350-11	Pharbetol	1000 in 1 BOTTLE, PLASTIC	TABLET, COATED	1000		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73057-350	PHARBETOL (ACETAMINOPHEN 500MG) TABLET, COATED [ULAI HEALTH LLC]	3	Current NDC, Legacy NDC, 2 package rows	20250122_c9d3cee1-531c-439f-ae19-07acd366aad6.zip

Products#

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

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

Pharbetol
Acetaminophen 500mg
HYPROMELLOSE, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TALC
TRIACETIN
ACETAMINOPHEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73057-350	73057-350-11, 73057-350-08

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
Name	UNII	Kind
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TRIACETIN	XHX3C3X673	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pharbetol	ACETAMINOPHEN 500MG	Ulai Health LLC	c9d3cee1-531c-439f-ae19-07acd366aad6	2025-01-20	Warnings	Exact identifier ndc (package): 73057-350-08 ndc (package): 73057-350-11 ndc (product): 73057-350 ndc11 (package): 73057035008 ndc11 (package): 73057035011 spl id: 2c2a6b82-dd55-8cf9-e063-6294a90a68f7 spl set id: c9d3cee1-531c-439f-ae19-07acd366aad6

Reported adverse events (FAERS/openFDA)#

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