NDC 62337-415 Pyrantel Pamoate

Product Information

Pyrantel Pamoate is product labeled by Neogen Corporation Dba Columbia Laboratories. The product's dosage form is and is administered via form.

Product Code62337-415
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Pyrantel Pamoate
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Neogen Corporation Dba Columbia Laboratories
Labeler Code62337
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-17-2012
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2021
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

What are the uses for Pyrantel Pamoate?


Product Packages

NDC 62337-415-16

Package Description: 473.2 mL in 1 BOTTLE, PLASTIC

NDC 62337-415-32

Package Description: 946.4 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What are Pyrantel Pamoate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • PYRANTEL PAMOATE (UNII: 81BK194Z5M)
  • PYRANTEL (UNII: 4QIH0N49E7) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCROSE (UNII: C151H8M554)
  • VANILLA (UNII: Q74T35078H)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

* Please review the disclaimer below.

Patient Education

Pyrantel

Pyrantel is pronounced as (pi ran' tel)

Why is pyrantel medication prescribed?
Pyrantel, an antiworm medication, is used to treat roundworm, hookworm, pinworm, and other worm infections.This medication is sometimes prescribed for other uses; ask you...
[Read More]

* Please review the disclaimer below.

Pyrantel Pamoate Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients (In Each 1 Tsp)



Pyrantel base: 250 mg

(as Pyrantel Pamoate)


Purpose



Pinworm treatment


Use



for the treatment of pinworms.


Warnings



Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.


Directions



  • Shake well before use.
  • Take only according to directions and do not exceed the recommended dosage unless directed by a physician.
  • Medication should only be taken one time as a single dose, do not repeat treatment - unless directed by a physician.
  • When one individual in a household has pinworms, the entire household should be treated unless otherwise advised.
  • This product can be taken any time of day, with or without meals. It may be taken alone or with milk or juice.
  • Use of a laxative is not necessary prior to, during, or after medication.
  • 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, not to exceed 1 gram (4 teaspoonfuls).
  • Dosage information: Each 5 mL (1 teaspoonful) of Pyrantel Pamoate Suspension contains the equivalent of 250 mg of Pyrantel Base.
  • Read package insert carefully before taking this medication.
  • If any worms other than pinworms are present before or after treatment, consult a physician.
  • If any symptoms or pinworms are still present after treatment, consult a physician.
  • Less than 25 Pounds or under 2 years old................Do not us unless directed by a physician.

    25 to 37 Pounds....................................................½ teaspoonful (125 mg)

    38 to 62 Pounds....................................................1 teaspoonful (250 mg)

    63 to 87 Pounds....................................................1½ teaspoonfuls (375 mg)

    88 to 112 Pounds..................................................2 teaspoonfuls (500 mg)

    113 to 137 Pounds................................................2½ teaspoonfuls (625 mg)

    138 to 162 Pounds................................................3 teaspoonfuls (750 mg)

    163 to 187 Pounds................................................3½ teaspoonfuls (875 mg)

    188 Pounds and over.............................................4 teaspoonfuls (1000 mg)


Other Information



  • Recommended storage: Store at temperature between 15°C - 30°C (59°F - 86°F).

Inactive Ingredients



BHT, Citric Acid, Flavor, Potassium Sorbate, Purified water, Sodium Benzoate, Sucrose, Xanthan gum


Questions?



Call 859/254-1221 or toll-free 800/621-8829.


Pyrantel Pamoate Oral Suspension Usp(Pyrantel Base: 50 Mg / Ml)Pinworm Treatment



Drug Facts

Active Ingredients

(in each 1 tsp)

Pyrantel base: 250 mg

(as Pyrantel Pamoate)

Purpose

Pinworm treatment

Use for the treatment of pinworms.

Warnings

Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

If pregnant or if you have liver disease, do not take this product unless directed by a physician.

When using this product, abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness may occur.

Stop use and ask a doctor if abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness persist.


Directions

  • Shake well before use.
  • Take only according to directions and do not exceed the recommended dosage unless directed by a physician.
  • Medication should only be taken one time as a single dose, do not repeat treatment - unless directed by a physician.
  • When one individual in a household has pinworms, the entire household should be treated unless otherwise advised.
  • This product can be taken any time of day, with or without meals. It may be taken alone or with milk or juice.
  • Use of a laxative is not necessary prior to, during, or after medication.
  • 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, not to exceed 1 gram (4 teaspoonfuls).
  • Dosage information: Each 5 mL (1 teaspoonful) of Pyrantel Pamoate Suspension contains the equivalent of 250 mg of Pyrantel Base.
  • Read package insert carefully before taking this medication.
  • If any worms other than pinworms are present before or after treatment, consult a physician.
  • If any symptoms or pinworms are still present after treatment, consult a physician.
  • Less than 25 Pounds or under 2 years old................Do not us unless directed by a physician.

    25 to 37 Pounds....................................................½ teaspoonful (125 mg)

    38 to 62 Pounds....................................................1 teaspoonful (250 mg)

    63 to 87 Pounds....................................................1½ teaspoonfuls (375 mg)

    88 to 112 Pounds..................................................2 teaspoonfuls (500 mg)

    113 to 137 Pounds................................................2½ teaspoonfuls (625 mg)

    138 to 162 Pounds................................................3 teaspoonfuls (750 mg)

    163 to 187 Pounds................................................3½ teaspoonfuls (875 mg)

    188 Pounds and over.............................................4 teaspoonfuls (1000 mg)

    Other information

    • Recommended storage: Store at temperature between 15°C - 30°C (59°F - 86°F).
    • Inactive Ingredients

      BHT, Citric Acid, Potassium Sorbate, Purified water, Sodium Benzoate, Sucrose, Xanthan gum

      Questions? Call 859/254-1221 or toll-free 800/621-8829.

      Manufactured for: Columbia Laboratories™, 944 Nandino Blvd, Lexington, KY 40511

      

      PYRANTEL PAMOATE

      READ THIS INSERT THOROUGHLY BEFORE TAKING THIS PRODUCT.

      This brochure will tell you about pinworms and how to treat infections effectively with Pyrantel Pamoate. Many who have pinworms do not have symptoms. Nevertheless, many will experience itching in and around the rectal opening. The itching may be very annoying and continued scratching can cause an irritation in this area. The itching may be presented at night when sleeping. That is why restless sleep is sometimes a sign of pinworms, especially in children. It is important for you to realize that you should only treat with Pyrantel Pamoate if you have seen and identified the pinworms.

      Pinworms look like tiny white threads. The female pinworm is about ½ long (the male pinworm is shorter). They live in the bowel. Usually, at night, the female travels to the rectal opening and lays eggs within the skin folds around the opening. This usually takes place within one to two hours after the child has been put to bed for the night. The sticky gelatin-like substance in which the eggs (they are too small to see) are deposited and the movement of the female pinworm may cause annoying itching and possibly restless sleep. By checking the rectal opening at this time, you can attempt to see the pinworm as described.

      The pinworm eggs normally survive for as long as three weeks. In that time, the pinworm egg may hatch and the pinworm will travel back within the rectal opening into the bowel. The pinworm reaches maturity in the bowel within two to six weeks and the life cycle repeats itself.

      Scratching will cause pinworm eggs to stick to the fingers. Reinfection will result if the fingers are placed in the mouth. The eggs, which are too small to see, contaminate whatever they come in contact with: bed clothes, underwear, toys, hands, and food touched by contaminated hands. Even eggs floating in the air can be swallowed and cause infection. Eggs deposited in the environment, as stated above, can survive for as long as three weeks. Pinworms are highly contagious. Even the cleanest and most careful people can get them.

      After treatment with Pyrantel Pamoate, there are some rules to follow to try to prevent spreading to others and reinfection:

      • Wash hands and fingernails with soap often during the day, especially before eating and after using the toilet.
      • Wear tight underpants both day and night. Change them daily.
      • For several days after treatment, clean the bedroom floor by vacuuming or damp mopping. Avoid dry sweeping that may stir up dust.
      • After treatment, wash bed linens and night clothes (don't shake them).
      • Keep the toilet seats clean.

* Please review the disclaimer below.