Label: PINWORM MEDICINE- pyrantel pamoate suspension

  • NDC Code(s): 10956-778-01, 10956-778-02
  • Packager: REESE PHARMACEUTICAL CO.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • ACTIVE INGREDIENT

    Active ingredient (in each mL)

    Pyrantel Pamoate  144mg/mL (the equivalent of 50mg pyrantel base)

  • PURPOSE

    Purpose

    Anthelimintic

  • INDICATIONS & USAGE

    Uses for the treatment of pinworns

  • WARNINGS

    Warnings  Do not exceed recommended dosage

  • ASK DOCTOR

    Ask a doctor before use if

    • you're pregnant
    • have liver disease
  • WHEN USING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • shake well before use
    • read bottle label and package insert carefully before taking this medication
    • treat the entire household unless otherwise advised
    • do not repeat treatment unless directed by 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
    • it signs of pinworms persist after treatment, consult a doctor

    WeightDosage (taken as a single dose)
    Less than 25 lb. or under 2 yrs.oldDo not use unless directed by a doctor
    25-37 lb.1/2 teaspoonful
    38-62 lb.1 teaspoonful
    63-87 lb.1 1/2 teaspoonfuls
    88-112 lb.2 teaspoonfuls
    113-137 lb.2 1/2 teaspoonfuls
    138-162 lb.3 teaspoonfuls
    163-187 lb.3 1/2 teaspoonfuls
    188 lb. and over4 teaspoonfuls

  • INACTIVE INGREDIENT

    Inactive ingredients

    banana flavor, citric acid, gylcerin, lecithin, magnesium aluminum silicate, methylcellulose, povidone, simethicone, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, and water

  • PRINCIPAL DISPLAY PANEL

    image of cartonimage of carton

  • INGREDIENTS AND APPEARANCE
    PINWORM  MEDICINE
    pyrantel pamoate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-778
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)  
    POVIDONE (UNII: FZ989GH94E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBANANAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10956-778-011 in 1 CARTON09/28/2022
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:10956-778-022 in 1 CARTON09/28/2022
    230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02409/28/2022
    Labeler - REESE PHARMACEUTICAL CO. (004172052)
    Registrant - REESE PHARMACEUTICAL CO. (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    LGM Pharma Solutions, LLC117549198manufacture(10956-778)
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