Label: PRONTO PLUS- pyrantel pamoate liquid

  • 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 November 10, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each ½ TSP)

    Pyrantel pamoate 360 mg

    (equivalent to 125mg / ½ TSP pyrantel base)

  • Purpose

    Pinworm treatment

  • Use

    for the treatment of pinworms

  • Warnings

    Ask a doctor before use if

    • you are pregnant
    • you have liver disease

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

    Keep out of reach of children.

    Overdose Warning

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • read package insert carefully before using. Use only according to directions. Do not exceed the recommended dosage unless directed by a doctor.
    • shake well before using
    • adults and children 2 years of age and older: dose one time as a single dose; do not repeat treatment unless directed by a doctor.
    • find the right dose on chart below. Use weight to dose.
    • use enclosed dosing cup. Do not use with any other device.
    • take any time of day, with or without meals. May be taken alone or with milk or fruit juice. Use of a laxative is not needed before, during, or after taking Pronto Plus.
    • 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, ask a doctor
    • if any symptoms or pinworms are still present after treatment, ask a doctor
    Weight (lbs)Single Dose (TSP)
    Under 25 lbs or under 2 yearsAsk a doctor
    25-37½
    38-621
    63-871 ½
    88-1122
    113-1372 ½
    138-1623
    163-1873 ½
    188 and over4
  • Other information

    The maximum dosage listed (4 TSP) contains 16 mg of sodium. Keep carton for full drug facts. Store at 15°C - 25°C (59°F - 77°F).

  • Inactive ingredients

    cherry flavor, citric acid, glycerin, lecithin, magnesium aluminum silicate, methylcellulose, povidone, purified water, simethicone, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

  • SPL UNCLASSIFIED SECTION

    Distributed by: INSIGHT Pharmaceuticals Corp.
    Langhorne, PA 19047-1749 © 2010 Insight Pharmaceuticals Corporation

  • Questions?

    Call 1-888-542-3546
    www.prontoplus.com

  • PRINCIPAL DISPLAY PANEL - 59 mL Carton

    FULL PRESCRIPTION STRENGTH

    PRONTO®
    PLUS

    Pyrantel Pamoate Suspension

    Pinworm Treatment

    Doctor Recommended Ingredient

    • Eliminates Pinworms with One Dose
    • Relieves Itching and Irritation
      from Pinworms
    • Child Resistant Cap

    Great Cherry Taste
    Sugar Free

    2 FL OZ (59 mL)

    NEW FAMILY SIZE

    Do not use if foil seal under bottle cap imprinted with
    "Sealed for Your Protection" is broken or missing.

    Principal Display Panel - 59 mL Carton
  • INGREDIENTS AND APPEARANCE
    PRONTO PLUS   PINWORM TREATMENT
    pyrantel pamoate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-240
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrantel pamoate (UNII: 81BK194Z5M) (Pyrantel - UNII:4QIH0N49E7) Pyrantel pamoate5 mL  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    povidone (UNII: FZ989GH94E)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sorbitol (UNII: 506T60A25R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-240-2424 in 1 CASE
    11 in 1 CARTON
    159 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart357B09/20/2010
    Labeler - Insight Pharmaceuticals LLC (176792315)
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