PYRANTEL PAMOATE SUSPENSION [PROMEX LLC]

PYRANTEL PAMOATE SUSPENSION [PROMEX LLC]
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NDC 58988-1770-1
Set ID e68c503a-6f79-4f83-a6f3-c12a13fb06a0
Category HUMAN OTC DRUG LABEL
Packager ProMex LLC
Generic Name
Product Class
Product Number
Application Number PART357B
  • 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)

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