FDA.reportPublic FDA data

Pharbetol

Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2018-05-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:57:32

Label at a glance#

ProductPharbetol
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

Temporarily relieves minor aches and pains due to: • headache • backache • minor pain of arthritis • toothache • muscular aches • menstrual cramps Temporarily reduces fever

Dosage and administration

• do not take more than directed (see overdose warning). • Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor. • Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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:

  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • 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 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.
  • 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

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning).
  • Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
  • Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call: (866) 562-2756

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strenght Acetaminophen 500mg
Extra Strenght Acetaminophen 500mg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-6408-12020-12-01C16284748780-19d75b9d0-5281-f424-e053-dadaa90a57ceDrug Facts
68788-6408-22020-12-01C16284748780-19d75b9d0-5281-f424-e053-dadaa90a57ceDrug Facts
68788-6408-32020-12-01C16284748780-19d75b9d0-5281-f424-e053-dadaa90a57ceDrug Facts
68788-6408-42020-12-01C16284748780-19d75b9d0-5281-f424-e053-dadaa90a57ceDrug Facts
68788-6408-52020-12-01C16284748780-19d75b9d0-5281-f424-e053-dadaa90a57ceDrug Facts
68788-6408-12020-01-31C16284748780-19d75b9d0-5281-f424-e053-dadaa90a57ceDrug Facts
68788-6408-22020-01-31C16284748780-19d75b9d0-5281-f424-e053-dadaa90a57ceDrug Facts
68788-6408-32020-01-31C16284748780-19d75b9d0-5281-f424-e053-dadaa90a57ceDrug Facts
68788-6408-42020-01-31C16284748780-19d75b9d0-5281-f424-e053-dadaa90a57ceDrug Facts
68788-6408-52020-01-31C16284748780-19d75b9d0-5281-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-376-06EA - Each16103-376b0ec28db-7535-413e-805f-e1416eeca91812012-07-24
16103-376-08EA - Each16103-376b9284189-e1cd-4f69-88be-fb02466b57ca12012-07-24
16103-376-11EA - Each16103-3767d6a6a6a-b98e-44d2-8664-e2351539d62b12012-07-24

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
68788-640868788-6408-2, 68788-6408-3, 68788-6408-4, 68788-6408-5, 68788-6408-1
16103-376

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
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT

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
PharbetolACETAMINOPHENPharbest Pharmaceuticals, Inc.04dbd98f-c74d-43b2-8bda-74f18be7cf6c2025-12-24WarningsExact identifier
ndc (product): 16103-376
55e17181-fe6e-400c-aa74-e86a8d76cc27ad3a5b2c-93e1-4d7d-94c9-636f5270dc0a2020-12-01WarningsExact identifier
spl set id: ad3a5b2c-93e1-4d7d-94c9-636f5270dc0a

Reported adverse events (FAERS/openFDA)#

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