Label: PARASITOL- pyrantel pamoate suspension

  • NDC Code(s): 53145-101-01, 53145-101-11
  • Packager: Menper Distributors Inc.
  • Category: HUMAN OTC DRUG LABEL

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 August 9, 2021

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    PYRANTEL PAMOATE 144 MG (equivalent to 50 mg pyrantel base)

  • PURPOSE

    PURPOSE

    Pinworm treatment

  • INDICATIONS & USAGE

    USES

    FOR THE TREATMENT OF PINWORMS.

  • WARNINGS

    WARNINGS

    Do not Exceed recommended usage

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

    Ask a doctor before use if you have liver disease

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, seek medical attention or contact a Poison Control Center Immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    Read package insert carefully before taking this medication. Take only according to directions and do not exceed the recommended dosage unless direct by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless direct by a doctor. 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 treatmen, consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor.

     Weight Single Dose
     Less than 25 pounds or under 2 years of age Do not use unless directed by a doctor
     25 to 37 pounds 1/2 teaspoonful (2.5 mL)
     38 to 62 pounds    1 teaspoonful (5 mL)
     63 to 87 pounds 1 1/2 teaspoonfuls (7.5 mL)
     88 to 112 pounds 2 teaspoonfuls (10 mL)
     113 to 137 pounds 2 1/2 teaspoonfuls (12.5 mL)
     138 to 162 pounds3 teaspoonfuls (15 mL) 
     163 to 187 pounds3 1/2 teaspoonfuls (17.5 mL) 
     188 pounds and over4 teaspoonfuls (20 mL) 

     Shake well before use. This product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during, or after medication.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    acesulfame potassium, cherry flavor, citric acid, glycerin, methylparaben, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium bezoate, sodium carboximethylcellulose, sodium citrate, sorbitol, water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    PARASITOL_Drug Facts

  • 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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-101-111 in 1 BOX01/01/2013
    1NDC:53145-101-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart357B01/01/2013
    Labeler - Menper Distributors Inc. (101947166)