Label: CVS PINWORM TREATMENT- 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 December 15, 2016

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

  • 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 carton

  • INGREDIENTS AND APPEARANCE
    CVS PINWORM TREATMENT 
    pyrantel pamoate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-618
    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:69842-618-022 in 1 CARTON12/15/2016
    130 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 finalpart357B12/15/2016
    Labeler - CVS PHARMACY INC (062312574)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma079424083manufacture(69842-618) , label(69842-618)