Label: PYRANTEL PAMOATE- pyrantel pamoate suspension

  • NDC Code(s): 51072-088-00, 51072-088-01
  • Packager: Jefferson Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 11, 2018

If you are a consumer or patient please visit this version.

  • PURPOSE

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

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  • Drug Facts

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

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  • Uses

    • For pinworm treatment
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  • 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.
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  • Do not use

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

    • Shake well before use.
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  • 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.
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  • Dosage Information

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

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  • 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)

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  • Other Information

    Each teaspoonful contains: Potassium 5 mg.

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  • STORAGE AND HANDLING

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

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  • Inactive Ingredients

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

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  • QUESTIONS

    Questions? 1-888-215-1256

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  • SPL UNCLASSIFIED SECTION

    PEEL BACK AT CORNER FOR IMPORTANT PRODUCT INFORMATION

    MANUFACTURED IN THE USA

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    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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children

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  • 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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  • INGREDIENTS AND APPEARANCE
    PYRANTEL PAMOATE 
    pyrantel pamoate suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51072-088
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor VANILLA (custard) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51072-088-00 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2015
    2 NDC:51072-088-01 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part357B 11/21/2015
    Labeler - Jefferson Labs (832848639)
    Establishment
    Name Address ID/FEI Business Operations
    Jefferson Labs 832848639 manufacture(51072-088)
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