Label: PYRANTEL PAMOATE tablet
- NDC Code(s): 58988-1760-1
- Packager: ProMex LLC
- Category: HUMAN OTC DRUG LABEL
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.
Updated January 2, 2018
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- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each tablet)
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
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
INGREDIENTS AND APPEARANCE
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)