Pyrantel Pamoate description, usages, side effects, indications, overdosage, supplying and lots more!

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Pyrantel Pamoate

Aurora Pharmaceutical LLC

Pyrantel Pamoate Suspension


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Each 1 mL contains: Pyrantel base (as Pyrantel Pamoate) 50 mg

Purpose

Pinworm treatment

Pyrantel Pamoate Uses

  • For pinworm treatment

Warnings

  • Abdominal cramps, nausea, vomiting, diarrhea, headache or dizziness sometimes occur after taking this drug. If any of these conditions persist, consult a physician.
  • Keep this and all medications out of reach of children.
  • In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Do not use

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

When using this product

  • Shake well before use.

Directions

  • Adults and children 2 years to 12 years of age may take this product. Take the dosage in Table I according to the body weight of the individual treated. Do not exceed 4 teaspoonful (20.0 mL) of Pyrantel Pamoate Suspension.
  • Carefully read additional product information (located on the inside of label) before using this medication. 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. See WARNINGS. 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.
  • 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.

Dosage Information

Each mL of Pyrantel Pamoate Suspension contains the equivalent of 50 mg of Pyrantel Base (as Pyrantel Pamoate).

Table I. Pyrantel Pamoate Suspension Dosage Guide
Less than 25 lbs.
(11 kg) or under 2 years old
Do not use unless directed by a physician
25-37 lbs. (11-16 kg) 1/2 teaspoonful (2.5 mL)
38-62 lbs. (17-28 kg) 1 teaspoonful (5.0 mL)
63-87 lbs. (29-39 kg) 1½ teaspoonful (7.5 mL)
88-112 lbs. (40-50 kg) 2 teaspoonful (10.0 mL)
113-137 lbs. (51-62 kg) 2½ teaspoonful (12.5 mL)
138-162 lbs. (63-73 kg) 3 teaspoonful (15.0 mL)
163-187 lbs. (74-84 kg) 3½ teaspoonful (17.5 mL)
188 lbs. (85 kg and over) 4 teaspoonful (20.0 mL)

Other Information

Store at 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F). Do not freeze.

Inactive Ingredients

Citric acid, potassium sorbate, purified water, propylene glycol, sodium benzoate, sucralose, vanilla custard flavor, xanthan gum.

Questions?

1-888-215-1256

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256
www.aurorapharmaceutical.com

IN 50-1227  04/2013

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

NDC 51072-065-00

ORAL-PRO

Pyrantel Pamoate
Suspension

Pinworm Treatment
50 mg/mL Pyrantel Base

Pharmacy Bulk Pack

Keep Out of Reach of Children

32 fl. oz. (946 mL)

Pyrantel Pamoate

Pyrantel Pamoate

Pyrantel Pamoate SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51072-065
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pyrantel Pamoate pyrantel 5 g

Inactive Ingredients

Ingredient Name Strength
propylene glycol
XANTHAN GUM
Sucralose
SODIUM BENZOATE
POTASSIUM SORBATE
ANHYDROUS CITRIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51072-065-00 946 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partB part357B 2013-04-19


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Be sure to consult your doctor before taking any medication!
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