Mebendamax Pinworm (as)

Mebendamax Pinworm (as)
SPL v2
SPL
SPL Set ID 1d75b912-3550-7d4c-e063-6294a90ad5fa
Route
ORAL
Published
Effective Date 2024-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrantel (180 mg)
Inactive Ingredients
Croscarmellose Sodium Silicon Dioxide Crospovidone Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Potassium Sorbate Talc Povidone K30

Identifiers & Packaging

Pill Appearance
Imprint: G Shape: round Color: yellow Size: 13 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-01

Description

Active ingredient (in each tablet) Purpose Pyrantel pamoate 180 (equivalent to 62.5mg of pyrantel base)......... Pinworm treatment


Medication Information

Description

Active ingredient (in each tablet) Purpose Pyrantel pamoate 180 (equivalent to 62.5mg of pyrantel base)......... Pinworm treatment

Use

For the treatment of pinworms.

Section 55105-1

Active ingredient (in each tablet)

Purpose

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

Pinworm treatment
Dist. By:

Pharmadel LLC.

New Castle, DE 19720

1-866-359-3478

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 Ingredients

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

Principal Display Panel

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
Ask A Doctor Before Use If You
  • have liver disease
  • are pregnant
Keep Out of Reach of Children.

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


Structured Label Content

Use

For the treatment of pinworms.

Section 55105-1 (55105-1)

Active ingredient (in each tablet)

Purpose

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

Pinworm treatment
Dist. By: (Dist. by:)

Pharmadel LLC.

New Castle, DE 19720

1-866-359-3478

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 Ingredients (Inactive ingredients)

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

Principal Display Panel

Stop Use and Ask A Doctor If (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
Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • have liver disease
  • are pregnant
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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