MebendamaX
Mebendamax Pinworm (AS)
1d75b912-3550-7d4c-e063-6294a90ad5fa
HUMAN OTC DRUG LABEL
Jun 18, 2025
Pharmadel LLC
DUNS: 030129680
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pyrantel Pamoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
INDICATIONS & USAGE SECTION
Use
For the treatment of pinworms.
DOSAGE & ADMINISTRATION SECTION
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 (1) dose as per weight) |
|
Less than 25 lb. or under 2 yrs. old |
do not use unless directed by a doctor |
|
25-37 lbs. |
2 tablets (125 mg) |
|
38-62 lbs. |
4 tablets (250 mg) |
|
63-87 lbs. |
6 tablets (375 mg) |
|
88-112 lbs. |
8 tablets (500 mg) |
|
113-137 lbs. |
10 tablets (625 mg) |
|
138-162 lbs. |
12 tablets (750 mg) |
|
163-187 lbs. |
14 tablets (875 mg) |
|
188 lbs. and over |
16 tablets (1,000 mg) |
INACTIVE INGREDIENT SECTION
Inactive ingredients
croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone k-30, silicon dioxide, talc
SPL UNCLASSIFIED SECTION
Dist. by:
Pharmadel LLC.
New Castle, DE 19720
1-866-359-3478
OTC - ACTIVE INGREDIENT SECTION
Active ingredient & Purpose
|
Active ingredient (in each tablet) |
Purpose |
|
Pyrantel pamoate 180 (equivalent to 62.5mg of pyrantel base)......... |
Pinworm treatment |
WARNINGS SECTION
Warnings
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.