Other
Drug Facts
Pyrantel Pamoate Suspension
FDA Label NDC 58988-1770
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Promex Llc for the product Pyrantel Pamoate (NDC 58988-1770). 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 other, active ingredient (in each 1ml), purpose, use, otc - ask doctor, otc - pregnancy or breast feeding, directions, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 1Ml)
Pyrantel Pamoate 144 mg/mL
(50mg pyrantel base per mL)
Purpose
Anthelmintic
Use
for the treatment of pinworms.
Otc - Ask Doctor
*Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occurs after taking this drug. If any of these conditions persist, consult a doctor.
Otc - Pregnancy Or Breast Feeding
*If you are pregnant or have liver disease, do not take this product unless directed by a doctor.
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. Do not exceed 1 gram (1000 mg).
| Weight | Dosage (Taken as a single dose) |
|---|---|
| Under 25 lbs or 2 yrs. | Don't use unless directed by a doctor |
| 25-37 lbs | ½ teaspoonful |
| 38-62 lbs | 1 teaspoonful |
| 63-87 lbs | 1 ½ teaspoonful |
| 88-112 lbs | 2 teaspoonful |
| 113-137 lbs | 2 ½ teaspoonful |
| 138-162 lbs | 3 teaspoonful |
| 163-187lbs | 3 ½ teaspoonful |
| over 188 lbs | 4 teaspoonful |
*Read package insert carefully before taking this medication. Take only according to directions and do not exceed the 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 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 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.
Otc - Keep Out Of Reach Of Children
Keep out of Reach of Children. In case of accidental overdose/ingestion contact a poison control center immediately.
Inactive Ingredients
Purified Water, Glycerin, Sugar, Flavor, Xanthan Gum, Citric Acid, Sodium Benzoate and Potassium Sorbate
Principal Display Panel - 30 Ml Bottle Carton
VERMISOL
SUSPENSION
1 oz (30 ml)
Principal Display Panel (30 ml Bottle Carton)
* Please review the disclaimer below.
