FDA.reportPublic FDA data

PHARBETOL

Manufacturer
Pharbest Pharmaceuticals, Inc.
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:28:17

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 more than 10 days unless directed by a doctor children under 12 years  ask a doctor

Storage and handling

Tamper Evident: do not use if imprinted safety seal under cap is broken or missing store at 20 o -25 o C (68 o -77 o F), excursions permitted between 15-30°C (59-86°F)

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

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:
  • 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 4000 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 pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you have 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

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 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 more than 10 days unless directed by a doctor

    children under 12 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 at 20o-25oC (68o-77oF), excursions permitted between 15-30°C (59-86°F)

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 16103-350-08

Manufactured in the USA

Etra Strength

*COMPARE TO the active ingredients in Etra Strength TYLENOL® Caplet

PHARBETOL

Acetaminophen 500 mg each

Pain Reliever/Fever Reducer

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

100 CAPLETS

Pharbetol (Acetaminophen) 500 mg Caplet Product LabelPharbetol (Acetaminophen) 500 mg Caplet Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN3
1293942Pharbetol 500 MG Oral TabletPSN3
1293942acetaminophen 500 MG Oral Tablet [Pharbetol]SBD3
198440acetaminophen 500 MG Oral TabletSCD3
198440APAP 500 MG Oral TabletSY3
1293942APAP 500 MG Oral Tablet [Pharbetol]SY3
1293942Pharbetol 500 MG Oral TabletSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-350-042024-12-31C16284748780-1d6a99b39-6a51-a426-e053-dadaa90af4c2Drug Facts
16103-350-082024-12-31C16284748780-1d6a99b39-6a51-a426-e053-dadaa90af4c2Drug Facts
16103-350-102024-12-31C16284748780-1d6a99b39-6a51-a426-e053-dadaa90af4c2Drug Facts
16103-350-112024-12-31C16284748780-1d6a99b39-6a51-a426-e053-dadaa90af4c2Drug Facts
16103-350-042022-01-28C16284748780-1d6a99b39-6a51-a426-e053-dadaa90af4c2Drug Facts
16103-350-082022-01-28C16284748780-1d6a99b39-6a51-a426-e053-dadaa90af4c2Drug Facts
16103-350-102022-01-28C16284748780-1d6a99b39-6a51-a426-e053-dadaa90af4c2Drug Facts
16103-350-112022-01-28C16284748780-1d6a99b39-6a51-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-350-04PHARBETOL1 in 1 CARTONTABLET, COATED13
16103-350-04PHARBETOL30 in 1 BOTTLE, PLASTICTABLET, COATED303
16103-350-08PHARBETOL100 in 1 BOTTLE, PLASTICTABLET, COATED1003
16103-350-08PHARBETOL1 in 1 CARTONTABLET, COATED13
16103-350-10PHARBETOL500 in 1 BOTTLE, PLASTICTABLET, COATED5003
16103-350-11PHARBETOL1000 in 1 BOTTLE, PLASTICTABLET, COATED10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-350-04EA - Each16103-350526744b9-dea5-417e-b300-418dedf58c0412019-04-11
16103-350-08EA - Each16103-350b5389dbb-d3cb-413e-b5e6-bf0eac6a6d0c12019-04-11
16103-350-10EA - Each16103-350fc23c7ec-3900-4d7f-9ada-9c394688f92c12022-06-06
16103-350-11EA - Each16103-3502d652227-a39c-44fe-abba-8910303a8c5912019-04-11

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16103-35016103-350-04, 16103-350-08, 16103-350-10, 16103-350-11

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
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TRIACETINXHX3C3X673IACT

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 500MGPharbest Pharmaceuticals, Inc.27337be9-e279-460e-903e-ae44630995992025-12-24WarningsExact identifier
ndc (package): 16103-350-08
ndc (package): 16103-350-11
ndc (package): 16103-350-04
ndc (package): 16103-350-10
ndc (product): 16103-350
ndc11 (package): 16103035008
ndc11 (package): 16103035004
ndc11 (package): 16103035010
ndc11 (package): 16103035011
spl id: e22d20db-8648-409d-b8db-78c1dddfbf6a
spl set id: 27337be9-e279-460e-903e-ae4463099599

Reported adverse events (FAERS/openFDA)#

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