Label: PARASITOL- pyrantel pamoate suspension

  • 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 March 18, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    PYRANTEL PAMOATE 144 MG/ML

  • PURPOSE

    PURPOSE

    PARASITICIDE

  • INDICATIONS & USAGE

    USES

    FOR THE TREATMENT OF PINWORMS.

  • WARNINGS

    WARNINGS

    ABDOMINAL CRAMPS, NAUSEA, VOMITING, DIARRHEA HEADACHES OR DIZZINESS SOMETIMES OCCUR AFTER TAKING THIS DRUG. IF ANY OF THOSE CONDITIONS PERSIST, CONSULT A DOCTOR. IF YOU ARE PREGNANT OR HAVE LIVER DISEASE, DO NOT TAKE THIS PRODUCT UNLESS DIRECTED BY A DOCTOR. PROTECT FROM EXCESSIVE HEAT AND FREEZING. SHAKE WELL.

    STORE AT CONTROLLED ROOM TEMPERATURE.

    READ WARNINGS AND PACKAGE INSERT CAREFULLY BEFORE TAKING THIS MEDICATION.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER AND CHILDREN 2 YEARS OF AGE TO UNDER TWELVE YEARS, ORAL DOSAGE IS A SINGLE DOSE OF 5MG OF PARASITOL PER POUND OR 11 MG PER KG OFBODY WEIGHT, NOT TO EXCEED 1 GM. TAKE ONLY ACCORDING TO DIRECTIONS AND DO NOT EXCEED RECOMMENDED DOSGE UNLESS DIRECTED BY A DOCTOR. MEDICATION SHOULD ONLY BE TAKEN ONE TIME AS A SINGLE DOSE. DO NOT REPEAT TREATMENT UNLESS DIRECTED BY A DOCTOR. WHEN ONE INDIVIDUAL IN HOUSEHOLD HAS PARSITES, THE ENTIRE HOUSEHOLD SHOULD BE TREATED UNLESS OTHERWISE ADVISED.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    PURIFIED WATER, SUCROSE, PROPYLENE GLYCOL, SODIUM CARBOXYMETHYLCELLULOSE, XANTHAN GUM, METHYLPARABEN, CHERRY FLAVOR AND PROPYLPARABEN

  • PRINCIPAL DISPLAY PANEL

    PARASITOL_Drug Facts

    PARASITOLbox_FR

    ParasitolLabel Artwork

  • INGREDIENTS AND APPEARANCE
    PARASITOL 
    pyrantel pamoate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL144 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-101-111 in 1 BOX
    1NDC:53145-101-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart357B01/01/2013
    Labeler - Menper Distributors Inc. (101947166)