FDA.reportPublic FDA data

VRMX 500 (Pyrantel Pamoate) Tablets

Manufacturer
OPMX LLC
Effective date
2024-02-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:08:27

Label at a glance#

ProductVRMX 500
Active ingredientPYRANTEL PAMOATE
Label structure11 sections

Storage and handling

Other information: store at 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each uncoated tablet)

Pyrantel Pamoate USP 180 mg (equivalent to 62.5mg of pyrantel base)

OTC - PURPOSE SECTION

Purpose

Antihelmintic

INDICATIONS & USAGE SECTION

Use: for the treatment of pinworms

WARNINGS SECTION

Warnings: Do not exceed recommended dosage

OTC - ASK DOCTOR SECTION

Ask a doctor before use if:

  • you're pregnant
  • you're nursing a baby
  • you have liver disease

OTC - WHEN USING SECTION

When using this product: abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these symptoms persist consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center rightaway.

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults, children 12 years of age and over, and children 2 years to under 12 years: Oral dossage is a single dose of 5 mg of pyrantel base per pound or 11 mg of pyrantel base per kilogram of body weight. Do not Exceed 1 gram (1000mg). Children Under 25lbs. or 2yrs: Don't use unless directed by a doctor.

READ PACKAGE INSERT CAREFULLY BEFORE TAKING THIS MEDICATION

WeightDosage (taken as a single dose)
Less than 25 lb. or under 2 yrs. oldDo not use unless directed by a doctor
25-37 lb.2 tablets
38-62 lb.4 tablets
63-87 lb.6 tablets
88-112 lb.8 tablets
113-137 lb.10 tablets
138-162 lb.12 tablets
163-187 lb.14 tablets
188 lb & over16 tablets

STORAGE AND HANDLING SECTION

Other information:

  • store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium sorbate, talc.

OTHER SAFETY INFORMATION

TAMPER-EVIDENT: DO NOT USE IF THE BLISTER IS CUT OR BROKEN

SPL UNCLASSIFIED SECTION

Exclusively distributed by

OPMX

Chula Vista, CA 91910

Questions or comments:

619-600-5632

MADE IN INDIA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-141-10

VRMX 500

Pyrantel Pamoate Tablets 180 mg

TREATMENT FOR PINWORMS

  • Recommended By Health Care Professionals ForThe Entire Family

​10 Tablets

cartoncarton

blisterblister

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199107pyrantel pamoate 180 MG Oral TabletPSN6
199107pyrantel 180 MG Oral TabletSCD6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-141-10VRMX 50010 in 1 BLISTER PACKTABLET106
69729-141-10VRMX 5001 in 1 CARTONTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-141VRMX 500 (PYRANTEL PAMOATE) TABLET [OPMX LLC]6Current NDC, Legacy NDC, 2 package rows20240209_e119cad8-9814-7d5a-e053-2995a90afde5.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-14169729-141-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSPOVIDONE2S7830E561IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PYRANTEL PAMOATE81BK194Z5MACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT

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
VRMX 500PYRANTEL PAMOATEOPMX LLCe119cad8-9814-7d5a-e053-2995a90afde52024-02-06WarningsExact identifier
ndc (package): 69729-141-10
ndc (product): 69729-141
ndc11 (package): 69729014110
spl id: 10c1a1dd-9165-2eec-e063-6294a90a3a38
spl set id: e119cad8-9814-7d5a-e053-2995a90afde5

Reported adverse events (FAERS/openFDA)#

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