Label: PYRANTEL PAMOATE- pyrantel pamoate suspension
- Label RSS
- Share
- NDC Code(s): 51072-088-00, 51072-088-01
- 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 December 11, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- Drug Facts
Close
Active Ingredient Purpose Each 1 mL contains: Pyrantel base Pinworm (as Pyrantel Pamoate) 50 mg treatment - Uses
- 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.
- Do not use
- If you are pregnant or have liver disease, do not take this product unless directed by a physician.
- When using this product
- Directions
- Adults and children 2 years to 12 years of age may take this product. Take the dosage in Table I according to the body weight of the individual treated. Do not exceed 4 teaspoonful (20.0 mL) of Pyrantel Pamoate Oral Suspension.
- 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 juice. Use of a laxative is not necessary prior to, during or after medication.
- Dosage Information
Each mL of Pyrantel Pamoate Oral Suspension contains the equivalent of 50 mg of Pyrantel Base (as Pyrantel Pamoate).
Close - Table 1. Pyrantel Pamoate Oral Suspension Dosage Guide
Close
Less than 25 lbs.
(11 Kg) or under 2 years old
Do not use unless
directed by a physician
25-37 lbs. (11-16 kg) 1/2 teaspoonful (2.5 mL) 38-62 lbs. (17-28 kg) 1 teaspoonful (5.0 mL) 63-87 lbs. (29-39 kg) 1 1/2 teaspoonful (7.5 mL) 88-112 lbs. (40-50 kg) 2 teaspoonful (10.0 mL) 113-137 lbs. (51-62 kg) 2 1/2 teaspoonful (12.5 mL) 138-162 lbs. (63-73 kg) 3 teaspoonful (15.0 mL) 163-187 lbs. (74-84 kg) 3 1/2 teaspoonful (17.5 mL) 188 lbs. (85 kg and over) 4 teaspoonful (20.0 mL) - Other Information
- STORAGE AND HANDLING
Store at 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F). Do not freeze.
Close - Inactive Ingredients
Citric acid, potassium sorbate, purified water, glycerin, sodium benzoate, sucralose, vanilla custard flavor, xanthan gum.
Close - QUESTIONS
- SPL UNCLASSIFIED SECTION
PEEL BACK AT CORNER FOR IMPORTANT PRODUCT INFORMATION
MANUFACTURED IN THE USA
Do not use if the seal is open or broken.
REORDER NO: 21013
Manufactured by:
Jefferson Labs
NORTHFIELD, MINNESOTA 55057
888-215-1256
IN 50-1419 07/2015
Close
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
NDC 51072-088-00
ORAL-PRO®
Pyrantel Pamoate
Oral Suspension
Pinworm Treatment
50 mg/mL Pyrantel Base
Pharmacy Bulk Pack
Keep Out of Reach of Children
32 fl. oz. (946 mL)
Close
- 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:51072-088-01 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017 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) CloseEstablishment Name Address ID/FEI Business Operations Jefferson Labs 832848639 manufacture(51072-088)