Label: PYRANTEL PAMOATE suspension
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- NDC Code(s): 51072-088-00, 51072-088-01, 51072-088-02, 51072-088-03
- Packager: Jefferson Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated May 24, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- Drug Facts
- Indications
-
Warnings
- Abdominal cramps, nausea, vomiting, diarrhea, headache or dizziness sometimes occur after taking this drug. If any of these conditions persist, consult a physician.
- Keep this and all medications out of reach of children.
- In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
- If you are pregnant or have liver disease, do not take this product unless directed by a physician.
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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 not to exceed 1 gram.
- Carefully read additional product information (located on the inside of label) before using this medication. Take only according to directions and do not exceed the recommended dosage unless directed by a physician. Medication should only be taken one time as a single dose, do not repeat treatment unless directed by a physician. 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 physician. If any symptoms or pinworms are still present after treatment, consult a physician.
- 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.
- Dosage Information
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Pyrantel Pamoate Oral Suspension Dosage Guide
Weight Dosage (taken as a single dose) Less than 25 pounds or
under 2 years old
Do not use unless directed by
a physician
25 to 37 pounds 1/2 teaspoonful (125 mg) 38 to 62 pounds 1 teaspoonful (250 mg) 63 to 87 pounds 1 1/2 teaspoonfuls (375 mg) 88 to 112 pounds 2 teaspoonfuls (500 mg) 113 to 137 pounds 2 1/2 teaspoonfuls (625 mg) 138 to 162 pounds 3 teaspoonfuls (750 mg) 163 to 187 pounds 3 1/2 teaspoonfuls (875 mg) 188 pounds and over 4 teaspoonfuls (1,000 mg) - Other Information
- STORAGE AND HANDLING
- Inactive Ingredients
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
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INGREDIENTS AND APPEARANCE
PYRANTEL PAMOATE
pyrantel pamoate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51072-088 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor VANILLA (custard) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51072-088-00 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2015 2 NDC:51072-088-02 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2022 3 NDC:51072-088-01 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017 4 NDC:51072-088-03 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part357B 11/21/2015 Labeler - Jefferson Labs (832848639) Establishment Name Address ID/FEI Business Operations Jefferson Labs 832848639 manufacture(51072-088)
