Label: 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 August 11, 2015

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  • Pinworm Treatment

    NDC 59779-538-02

    PYRANTEL PAMOATE

    (PYRANTEL BASE 50 mg/mL)

    Ages 2 to Adult

    • Full prescription strength
    • Single dose effectiveness
    • Sugar free
    • Liquid cup included

    Caramel Flavored Liquid

    Actual Product Size on Back Panel

    FAMILY SIZE

    2 FL OZ (60 mL)

  • OTHER SAFETY INFORMATION

    DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING OR IF CARTON IS OPENED.

  • Drug Facts

  • Active ingredient (in each 1 mL)

    Pyrantel pamoate 144 mg

    (equivalent to 50 mg pyrantel base)

  • Purpose

    Pinworm treatment

  • Use

    for the treatment of pinworms.

  • 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.

  • Directions

    • shake well before using
    • important - treat the entire household
    • take only one dose unless directed by a doctor

    Under 25 lbs or under age 2, consult a doctor

    25-37 lbs..... 1/ 2 tsp

    36-62 lbs.....1 tsp

    63-87 lbs.....1 1/ 2 tsps

    88-112 lbs....2 tsps

    113-137 lbs.....2 1/ 2 tsps

    138-162 lbs.....3 tsps

    163-187 lbs.....3 1/ 2 tsps

    over 187 lbs.....4 tsps

  • Other information

    • read package insert carefully before using
    • if signs of pinworms persist, see a doctor
  • STORAGE AND HANDLING

    • store at 15°-30°C (59°-86°F)
  • Inactive ingredients

    acesulfame potassium, citric acid, flavor, methylparaben, microcrystalline cellulose, polysorbate 80, propylene glycol, propylparaben, purified water, sodium benzoate, sodiumcarboxymethylcellulose, sodium citrate, sorbitol solution

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2015 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    Made in XXXXXXX

    V-32607

    CVS Quality

    Money Back Guarantee

  • PRINCIPAL DISPLAY PANEL

    CARA - CVS Pinworm Treatment

  • INGREDIENTS AND APPEARANCE
    PINWORM TREATMENT 
    pyrantel pamoate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-538
    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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCARAMELImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-538-021 in 1 CARTON08/11/2015
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart357B08/11/2015
    Labeler - CVS Pharmacy Inc. (062312574)
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