Otc - Purpose
Active ingredient (in each tablet) | Purpose |
Pyrantel pamoate 180 (equivalent to 62.5mg of pyrantel base)......... | Pinworm treatment |
Mebendamax Tablet
FDA Label NDC 55758-441
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Mebendamax (NDC 55758-441). 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, use, ask a doctor before use if you, stop use and ask a doctor if, keep out of reach of children., directions, inactive ingredients, dist. by:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
For the treatment of pinworms.
Ask A Doctor Before Use If You
- have liver disease
- are pregnant
Stop Use And Ask A Doctor If
- any symptoms or pinworms are still present after treatment
- any worms other than pinworms are present before or after treatment
- any of these symptoms that sometimes occur after taking the product persist:
- abdominal cramps
- nausea
- vomiting
- diarrhea
- headache
- dizziness
Keep Out Of Reach Of Children.
In case of an accidental overdose get medical help or contact a Poison Control Center right away.
Directions
READ THE PACKAGE CAREFULLY BEFORE TAKING THIS MEDICATION.
- take only according to directions
- 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
- when one individual in a household has pinworms, the entire household should be treated unless otherwise advised
- adults, children 12 years of age and over, and children 2 years to under 12 years of age:
- 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 before, during, or after medication
- oral dosage is a single dose of 5 mg of pyrantel base per pound or 11 mg of pyrantel base per kilogram of body weight not to exceed 1 gram (1000mg)
- children under 25 lbs. or 2yrs old: do not use unless directed by a doctor
| Weight | Dosage (taken as a single dose) |
| Less than 25 lb. or under 2 yrs. old | do not use unless directed by a doctor |
| 25-37 lbs. | 2 tablets |
| 38-62 lbs. | 4 tablets |
| 63-87 lbs. | 6 tablets |
| 88-112 lbs. | 8 tablets |
| 113-137 lbs. | 10 tablets |
| 138-162 lbs. | 12 tablets |
| 163-187 lbs. | 14 tablets |
| 188 lbs. and over | 16 tablets |
Inactive Ingredients
croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone k-30, silicon dioxide, talc
Dist. By:
Pharmadel LLC.
New Castle, DE 19720
1-866-359-3478
* Please review the disclaimer below.
