Label: 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 January 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each 1mL)

    Pyrantel Pamoate 144 mg/mL
    (50mg pyrantel base per mL)

  • Purpose

    Anthelmintic

  • Use

    for the treatment of pinworms.

  • Warnings

    *Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occurs after taking this drug. If any of these conditions persist, consult a doctor.

    *If you are pregnant or have liver disease, do not take this product unless directed by a doctor.

  • Directions

    Shake well before use. Adults, children 12 years of age and over, and children 2 years to under 12 years of age: Oral dosage is a single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams per kilogram, of body weight. Do not exceed 1 gram (1000 mg).

    WeightDosage (Taken as a single dose)
    Under 25 lbs or 2 yrs.Don't use unless directed by a doctor
    25-37 lbs½ teaspoonful
    38-62 lbs1 teaspoonful
    63-87 lbs1 ½ teaspoonful
    88-112 lbs2 teaspoonful
    113-137 lbs2 ½ teaspoonful
    138-162 lbs3 teaspoonful
    163-187lbs3 ½ teaspoonful
    over 188 lbs4 teaspoonful

    *Read package insert carefully 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 consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor.

    *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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children. In case of accidental overdose/ingestion contact a poison control center immediately.

  • Inactive Ingredients

    Purified Water, Glycerin, Sugar, Flavor, Xanthan Gum, Citric Acid, Sodium Benzoate and Potassium Sorbate

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    VERMISOL

    SUSPENSION

    1 oz (30 ml)

    PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

  • INGREDIENTS AND APPEARANCE
    PYRANTEL PAMOATE 
    pyrantel pamoate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-1770
    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
    Water (UNII: 059QF0KO0R)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sucrose (UNII: C151H8M554)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-1770-11 in 1 CARTON09/27/2002
    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 FINALpart357B09/27/2002
    Labeler - ProMex LLC (789974388)