Label: PYRANTEL PAMOATE suspension
- 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
Drug Label Information
Updated December 4, 2023
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- 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.
-
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
-
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
-
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 Drug M024 11/21/2015 Labeler - Jefferson Labs (832848639) Establishment Name Address ID/FEI Business Operations Jefferson Labs 832848639 manufacture(51072-088)
