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  5. Label Information: Pyrantel Pamoate

FDA Label for Pyrantel Pamoate

View Indications, Usage & Precautions

Table of Contents

    1. OTC - PURPOSE
    2. DRUG FACTS
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. DIRECTIONS
    8. DOSAGE INFORMATION
    9. TABLE 1.PYRANTEL PAMOATE ORAL SUSPENSION DOSAGE GUIDE
    10. OTHER INFORMATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENTS
    13. OTC - QUESTIONS
    14. OTHER
    15. OTC - KEEP OUT OF REACH OF CHILDREN
    16. PRINCIPAL DISPLAY PANEL - 946 ML BOTTLE LABEL

Pyrantel Pamoate Product Label

The following document was submitted to the FDA by the labeler of this product Jefferson Labs. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose



Pyrantel Pamoate Oral Suspension is used for the treatment of pinworms.


Drug Facts



Active IngredientPurpose
 Each 1 mL contains:
 Pyrantel base Pinworm
 (as Pyrantel Pamoate) 50 mg treatment


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


Table 1.Pyrantel Pamoate Oral 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)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



Each teaspoonful contains: Potassium 5 mg.


Storage And Handling



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, glycerin, sodium benzoate, sucralose, vanilla custard flavor, xanthan gum.


Otc - Questions



Questions? 1-888-215-1256


Other



PEEL BACK AT CORNER FOR IMPORTANT PRODUCT INFORMATION

MANUFACTURED IN THE USA

Do not use if the seal is open or broken.

REORDER NO: 21013

Manufactured by:
Jefferson Labs
NORTHFIELD, MINNESOTA 55057
888-215-1256
IN 50-1419  07/2015


Otc - Keep Out Of Reach Of Children



Keep Out of Reach of Children


Principal Display Panel - 946 Ml Bottle Label



NDC 51072-088-00

ORAL-PRO™

Pyrantel Pamoate

Oral Suspension

Pinworm Treatment

50 mg/mL Pyrantel Base

Pharmacy Bulk Pack

Keep Out of Reach of Children

32 fl. oz. (946 mL)


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