Label: PARASITEXX- pyrantel pamoate suspension

  • NDC Code(s): 70242-134-05
  • Packager: Dannso Corp./d.b.a. Essential Products
  • 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 June 27, 2017

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

  • Active Ingredient

    Active Ingredient (in each 1 ml) Purpose

    Active Ingredient (in each 1 ml) Purpose
    PYRANTEL PAMOATE Pinworm Treatment

  • Inactive Ingredient

    acesulfame potassium, cherry flavor, citric acid, glycerin, polysorbate 80, potassium sorbate, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol, water, xanthan gum.

  • Dosage

    Directions Read package insert careful before taking this medication. Take only according to directions and do not exceed the recommended dosage 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 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, or pinworms are still present after treatment, consult a doctor.

    WEIGHTS SINGLE DOSE
    Less than 26 pounds or under 2 years of age Do not use unless directed by a doctor
    25 to 37 pounds ½ teaspoonful (2.5 ml)
    38 to 62 pounds 1 teaspoonful (5 ml)
    63 to 87 pounds 1 ½ teaspoonfuls (7.5 ml)
    88 to 112 pounds 2 teaspoonfuls (10 ml)
    113 to 137 pounds 2 ½ teaspoonfuls (12.5 ml)
    138 to 162 pounds 3 teaspoonfuls (15 ml)
    163 to 187 pounds 3 ½ teaspoonfuls (17.5 ml)
    188 pounds and over 4 teaspoonfuls (20 ml)

    Shake well before use. This product can be taken any time of the 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.

  • Uses

    For the treatment of pinworms.

  • Warnings

    Do not exceed recommended dosage. When using this product abdominal cramps, nausea, diarrhea. Headache, or dizziness sometimes occurs after taking this drug. If this condition persists consult doctor.

  • ASK 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.

  • INDICATIONS & USAGE

    Uses for the treatment of pinworns

  • Keep out of reach of children.

    In case of accidental overdose, seek medical attention or contact a Poison Control Center immediately.

  • Other information

    Protect from excessive heat and freezing. Store at room temperature.

    Tamper-Evident Feature: do not use if printed seal around bottle neck is torn, broken or missing.

  • QUESTIONS

    Questions? 305-261-8762
    Monday – Friday 9am to 5pm EST.

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    PARASITEXX 
    pyrantel pamoate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-134
    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)  
    CHERRY (UNII: BUC5I9595W)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70242-134-051 in 1 CARTON07/01/2017
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart357B05/01/2017
    Labeler - Dannso Corp./d.b.a. Essential Products (059741071)
    Registrant - Dannso Corp./d.b.a. Essential Products (059741071)
    Establishment
    NameAddressID/FEIBusiness Operations
    All Pharma LLC078572520MANUFACTURE(70242-134)