PYRANTEL PAMOATE- pyrantel pamoate suspension
Aurora Pharmaceutical LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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ORAL-PRO™
Pyrantel Pamoate Suspension
Drug Facts
Active Ingredient
Each 1 mL contains: Pyrantel base (as Pyrantel Pamoate) 50 mg
Purpose
Pinworm treatment
Warnings
• Abdominal cramps, nausea, vomiting, diarhea, headache or dizziness sometimes occur after taking this drug. If any of these conditions persist, consult a physician.
• Keep this and all mediactions 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.
Directions
• Adults and children 2 years to 12 years of age may take this product. Take the dosage in Table 1 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 1.
Pyrantel Pamoate Suspension Dosage Guide
|
Less than25 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) | 1 1/2 teaspoonful (7.5 mL) |
| 88-112 lbs. (40-50 kg) | 2 teaspoonful (10.0 mL) |
| 113-137 lbs. (51-62 kg) | 2 1/2 teaspoonful (12.5 mL) |
| 138-162 lbs. (63-73 kg) | 3 teaspoonful (15.0 mL) |
| 163-187 lbs. (74-84 kg) | 3 1/2 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
PPEL BACK AT CORNER FOR IMPORTANT PRODUCT INFORMATION
MANUFACTURED IN THE USA
TAKE TIME OBSERVE LABEL DIRECTIONS
Do not use if the seal is open or broken
REORDER NO: 21013
MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256
www.aurorapharmaceutical.com
IN 50-1227 04/2013
| PYRANTEL PAMOATE
pyrantel pamoate suspension |
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| Labeler - Aurora Pharmaceutical LLC (832848639) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aurora Pharmaceutical LLC | 832848639 | manufacture(51072-065) | |