Otc - Purpose
Pyrantel Pamoate Oral Suspension is used for the treatment of pinworms.
Pyrantel Pamoate Suspension
FDA Label NDC 51072-088
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jefferson Labs for the product Pyrantel Pamoate (NDC 51072-088). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, drug facts, uses, warnings, do not use, when using this product, directions, dosage information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Drug Facts
| Active Ingredient | Purpose |
| Each 1 mL contains: | |
| Pyrantel base | Pinworm |
| (as Pyrantel Pamoate) 50 mg | treatment |
Uses
- For pinworm treatment
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
- Shake well before use.
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).
Table 1.Pyrantel Pamoate Oral Suspension Dosage Guide
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
Each teaspoonful contains: Potassium 5 mg.
Storage And Handling
Store at 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F). Do not freeze.
Inactive Ingredients
Citric acid, potassium sorbate, purified water, glycerin, sodium benzoate, sucralose, vanilla custard flavor, xanthan gum.
Otc - Questions
Questions? 1-888-215-1256
Other
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
Otc - Keep Out Of Reach Of Children
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)
* Please review the disclaimer below.
