OTC Medication Information: VRMX 500

VRMX 500- pyrantel pamoate tablet
OPMX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each uncoated tablet)

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

Purpose

Antihelmintic

Use: for the treatment of pinworms

Warnings: Do not exceed recommended dosage

Ask a doctor before use if:

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

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.

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

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

Weight	Dosage (taken as a single dose)
Less than 25 lb. or under 2 yrs. old	Do 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 & over	16 tablets

Other information:

• store at 15°-30°C (59°-86°F)

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

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

Exclusively distributed by

OPMX

Chula Vista, CA 91910

Questions or comments:

619-600-5632

MADE IN INDIA

NDC 69729-141-10

VRMX 500

Pyrantel Pamoate Tablets 180 mg

TREATMENT FOR PINWORMS

• Recommended By Health Care Professionals ForThe Entire Family

​10 Tablets

VRMX 500 pyrantel pamoate tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-141 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 180 mg

Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 6000 LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE CROSPOVIDONE CROSCARMELLOSE SODIUM POVIDONE, UNSPECIFIED POTASSIUM SORBATE SILICON DIOXIDE MAGNESIUM STEARATE TALC

Product Characteristics Color yellow Score no score Shape ROUND Size 13mm Flavor Imprint Code G Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69729-141-10 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69729-141-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part357B 06/10/2022

Labeler — OPMX LLC (029918743)

Revised: 06/2022 OPMX LLC