PYRANTEL PAMOATE suspension

Pyrantel Pamoate by

Drug Labeling and Warnings

Pyrantel Pamoate by is a Otc medication manufactured, distributed, or labeled by ProMex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each 1mL)

Pyrantel Pamoate 144 mg/mL
(50mg pyrantel base per mL)

Purpose

Anthelmintic

Use

for the treatment of pinworms.

Warnings

*Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occurs after taking this drug. If any of these conditions persist, consult a doctor.

*If you are pregnant or have liver disease, do not take this product unless directed by a doctor.

Directions

Shake well before use. Adults, children 12 years of age and over, and children 2 years to under 12 years of age: Oral dosage is a single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams per kilogram, of body weight. Do not exceed 1 gram (1000 mg).

Weight	Dosage (Taken as a single dose)
Under 25 lbs or 2 yrs.	Don't use unless directed by a doctor
25-37 lbs	½ teaspoonful
38-62 lbs	1 teaspoonful
63-87 lbs	1 ½ teaspoonful
88-112 lbs	2 teaspoonful
113-137 lbs	2 ½ teaspoonful
138-162 lbs	3 teaspoonful
163-187lbs	3 ½ teaspoonful
over 188 lbs	4 teaspoonful

*Read package insert carefully before taking this medication. Take only according to directions and do not exceed the recommended dosage unless directed by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless directed by a doctor. When one individual in a household has pinworms, the entire household should be treated unless otherwise advised. See Warnings. If any worms other than pinworms are present before or after treatment consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor.

*This product can be taken any time of day, with or without meals, it may be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during or after medication.

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children. In case of accidental overdose/ingestion contact a poison control center immediately.

Inactive Ingredients

Purified Water, Glycerin, Sugar, Flavor, Xanthan Gum, Citric Acid, Sodium Benzoate and Potassium Sorbate

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

VERMISOL

SUSPENSION

1 oz (30 ml)

INGREDIENTS AND APPEARANCE

PYRANTEL PAMOATE 
pyrantel pamoate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58988-1770
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrantel Pamoate (UNII: 81BK194Z5M) (Pyrantel - UNII:4QIH0N49E7)	Pyrantel	144 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Sucrose (UNII: C151H8M554)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Benzoate (UNII: OJ245FE5EU)
Potassium Sorbate (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58988-1770-1	1 in 1 CARTON	09/27/2002
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part357B	09/27/2002

Labeler - ProMex LLC (789974388)