Pharbetol

Manufacturer: A-S Medication Solutions
Effective date: 2021-02-26
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 23:38:34

Label at a glance#

ProductPharbetol Regular strength

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 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 11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 ...

Storage and handling

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact(866) 562-2756

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 11 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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

OTC - QUESTIONS SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-2156

NDC: 50090-2156-1 6 TABLET in a BOTTLE

Acetaminophen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
313782	acetaminophen 325 MG Oral Tablet	PSN	7
1298830	Pharbetol Regular Strength 325 MG Oral Tablet	PSN	7
1298830	acetaminophen 325 MG Oral Tablet [Pharbetol]	SBD	7
313782	acetaminophen 325 MG Oral Tablet	SCD	7
313782	APAP 325 MG Oral Tablet	SY	7
1298830	APAP 325 MG Oral Tablet [Pharbetol]	SY	7
1298830	Pharbetol 325 MG Oral Tablet	SY	7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-2156-1	2023-01-30	C162847	48780-1	f386c64a-0667-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-2156-1	PharbetolRegular strength	6 in 1 BOTTLE	TABLET	6		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2156	PHARBETOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [A-S MEDICATION SOLUTIONS]	7	Legacy NDC, 1 package rows	20210227_8cdbe98a-a6ce-4209-9c09-448f800f1d46.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-353-07	EA - Each	16103-353	be19f1cb-5a83-4ab8-a81c-dbc7b6c366b3	1	2013-05-02
16103-353-08	EA - Each	16103-353	d0efd342-8f78-4b8b-b2ab-963c13f461bf	1	2013-05-02
16103-353-11	EA - Each	16103-353	239e09b4-a5bc-4312-a3cc-d82250536ba3	1	2013-05-02

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Pharbetol Regular strength
Acetaminophen
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-2156	50090-2156-1
16103-353

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
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
STEARIC ACID	4ELV7Z65AP	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pharbetol Regular strength	ACETAMINOPHEN	Pharbest Pharmaceuticals, Inc.	e0a39957-d918-4125-88f9-0e550b976fa1	2025-12-24	Warnings	Exact identifier ndc (product): 16103-353
c0818fea-73e7-44a6-afb3-2538e54501a0			8cdbe98a-a6ce-4209-9c09-448f800f1d46	2021-02-26	Warnings	Exact identifier spl id: c0818fea-73e7-44a6-afb3-2538e54501a0 spl set id: 8cdbe98a-a6ce-4209-9c09-448f800f1d46

Reported adverse events (FAERS/openFDA)#

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