Label: PARASITOL- pyrantel pamoate tablet

  • NDC Code(s): 53145-306-30
  • Packager: Menper Distributors Inc.
  • 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 January 2, 2021

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

  • SPL UNCLASSIFIED SECTION

    CAUTION: DO NOT USE IF BLISTER PACK IS BROKEN

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each uncoated tablet)

    Pyrantel Pamoate USP 180 mg

    (equivalent to 62.5mg of pyrantel base)

  • PURPOSE

    Purpose

    Antihelmintic

  • INDICATIONS & USAGE

    Use:

    for the treatment of pinworms

  • WARNINGS

    Warnings: Do not exceed recommended dosage

    Ask a doctor before use if:

    • you're pregnant
    • you're nursing a baby
    • have liver disease

    When using this product: abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these symptoms persist, consult a doctor.

    Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • treat the entire family
    WeightDosage (taken as a single dose)
    Less than 25 lb. or under 2 yrs. oldDo not use unless directed by a doctor
    25-37 lb.2 tablets
    38-62 lb.4 tablets
    63-87 lb.6 tablets
    88-112 lb.8 tablets
    113-137 lb.10 tablets
    138-162 lb.12 tablets
    163-187 lb.14 tablets
    188 lb & over16 tablets

  • STORAGE AND HANDLING

    Other information:

    • store at 15°-30°C (59°-86°F)
  • SPL UNCLASSIFIED SECTION

    Distributed by

    MENPUR DISTRIBUTORS

    6500 N.W. 35th Ave., Miami, FL 33147

    www.menpurdistributors.com

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Lactose Monohydrate, Microcrystalline Cellulose, Croscarmellose Sodium, Polyvinyl Pyrollidone, Potassium Sorbate, Polyethylene Glycol 6000, Crospovidone, Colloidal Anhydrous Silica, Magnesium Stearate, Purified Talc.

  • PRINCIPAL DISPLAY PANEL

    NDC 53145-306-30

    Treatment for Pinworms

    Pyrantel Pamoate Tablets 180 mg

    PARASITOL

    For the Entire Family

    • Single Dose Effectiveness
    • Measured Table Dose
    • Recommended by Health Care Professionals

    30 Tablets

    PARASITOL 09-11-2020

  • INGREDIENTS AND APPEARANCE
    PARASITOL 
    pyrantel pamoate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-306
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL180 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-306-303 in 1 CARTON01/02/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart357B01/02/2021
    Labeler - Menper Distributors Inc. (101947166)