PHARBETOL

Manufacturer
Direct_Rx
Effective date
2019-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:17:46

Label at a glance#

ProductPHARBETOL
Active ingredientACETAMINOPHEN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Acetaminophen 500mg

OTC - PURPOSE SECTION


Pain reliever/fever reducer

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 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

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

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if:

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,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:

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.

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 INGREDIENT SECTION


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

OTC - QUESTIONS SECTION


Adverse drug event call: (866) 562-2756

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

861-50861-50

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-861-502023-10-09C16284748780-1f386c64a-3257-0266-e053-dadaa90a7c1aPHARBETOL
61919-861-502023-01-30C16284748780-1f386c64a-3257-0266-e053-dadaa90a7c1aPHARBETOL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-861-50EA - Each61919-86189b91d31-136f-4372-9c0f-10e702a9b10312019-08-06
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
61919-86161919-861-50
16103-376

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
07d9fe22-c3cb-485c-e063-6294a90acdfc8eec0f6d-389d-0502-e053-2a95a90ae45d2023-10-16WarningsExact identifier
spl set id: 8eec0f6d-389d-0502-e053-2a95a90ae45d

Reported adverse events (FAERS/openFDA)#

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