FDA.reportPublic FDA data

MebendamaX

Manufacturer
Pharmadel LLC
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:06:51

Label at a glance#

ProductMebendamaX Pinworm
Active ingredientPYRANTEL PAMOATE
Label structure7 sections

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each tablet)

Purpose

Pyrantel pamoate 180 (equivalent to 62.5mg of pyrantel base).........

Pinworm treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of pinworms.

Warnings

WARNINGS SECTION

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • have liver disease
  • are pregnant

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of an accidental overdose get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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
WeightDosage (taken as a single dose)
Less than 25 lb. or under 2 yrs. olddo 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 over16 tablets

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone k-30, silicon dioxide, talc

Dist. by:

SPL UNCLASSIFIED SECTION

Pharmadel LLC.

New Castle, DE 19720

1-866-359-3478

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MMaXPDPMMaXPDP

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-38355758-383-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE2S7830E561IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
TALC7SEV7J4R1UIACT
PYRANTEL PAMOATE81BK194Z5MACTIM
POVIDONE K30U725QWY32XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1d75eea0-ed6e-f1fa-e063-6294a90a51a712f56a34-15ba-949f-e063-6394a90a22d32024-07-17WarningsExact identifier
spl set id: 12f56a34-15ba-949f-e063-6394a90a22d3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.