PYRANTEL PAMOATE- pyrantel pamoate tablet 
ProMex 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.

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Pyrantel Pamoate

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).

WeightDosage (Taken as a single dose)
READ INSERT CAREFULLY BEFORE USE
25-37 lb2 tablet
38-62 lbs4 tablets
63-87 lbs6 tablets
88-112 lbs8 tablets
113-137 lbs10 tablets
138-162 lbs12 tablets
163-187 lbs14 tablets
over 188 lbs16 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

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

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
PYRANTEL PAMOATE 
pyrantel pamoate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-1760
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrantel Pamoate (UNII: 81BK194Z5M) (Pyrantel - UNII:4QIH0N49E7) Pyrantel180 mg
Inactive Ingredients
Ingredient NameStrength
Croscarmellose Sodium (UNII: M28OL1HH48)  
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58988-1760-12 in 1 CARTON09/27/2002
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart357B09/27/2002
Labeler - ProMex LLC (789974388)

Revised: 1/2018
Document Id: 590596c7-cde5-419a-b5d2-759b8d996fba
Set id: e68dd24a-93f8-4e2e-a698-d9ad9a7cebac
Version: 2
Effective Time: 20180102
 
ProMex LLC