Pyrantel Pamoate by ProMex LLC PYRANTEL PAMOATE tablet

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 tablet)

Pyrantel Pamoate 180 mg (62.5mg pyrantel base per 180 mg of pyrantel pamoate)

PURPOSE

Anthelmintic

Use

for the treatment of Pinworms.

Warnings

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

• If you are pregnant or have liver disease, don't take this product unless directed by a doctor.

Directions

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)
READ INSERT CAREFULLY BEFORE USE
25-37 lb	2 tablet
38-62 lbs	4 tablets
63-87 lbs	6 tablets
88-112 lbs	8 tablets
113-137 lbs	10 tablets
138-162 lbs	12 tablets
163-187 lbs	14 tablets
over 188 lbs	16 tablets

Take only according to directions and don't exceed 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 house hold 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

Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

VERMISOL
TABLET

Contains 20 Tablets

INGREDIENTS AND APPEARANCE

PYRANTEL PAMOATE 
pyrantel pamoate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58988-1760
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrantel Pamoate (UNII: 81BK194Z5M) (Pyrantel - UNII:4QIH0N49E7)	Pyrantel	180 mg

Inactive Ingredients
Ingredient Name	Strength
Croscarmellose Sodium (UNII: M28OL1HH48)
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58988-1760-1	2 in 1 CARTON	09/27/2002
1		10 in 1 BLISTER PACK; 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)