PYRANTEL PAMOATE SUSPENSION [JEFFERSON LABS]

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PYRANTEL PAMOATE SUSPENSION [JEFFERSON LABS]
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NDC 51072-088-00, 51072-088-01
Set ID e862b337-2991-4b56-8584-fd80dccd725f
Category HUMAN OTC DRUG LABEL
Packager Jefferson Labs
Generic Name
Product Class
Product Number
Application Number PART357B
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  • 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.

  • QUESTIONS

    Questions? 1-888-215-1256

  • SPL UNCLASSIFIED SECTION

    PEEL BACK AT CORNER FOR IMPORTANT PRODUCT INFORMATION

    MANUFACTURED IN THE USA

    image description

    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  06/2020

    image description

  • 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)

    PRINCIPAL DISPLAY PANEL - 32 oz Bottle Label

  • INGREDIENTS AND APPEARANCE
    PYRANTEL PAMOATE 
    pyrantel pamoate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51072-088
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScore    
    ShapeSize
    FlavorVANILLA (custard) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51072-088-00946 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2015
    2NDC:51072-088-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart357B11/21/2015
    Labeler - Jefferson Labs (832848639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jefferson Labs832848639manufacture(51072-088)
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