Label: PINAWAY- pyrantel pamoate suspension

  • NDC Code(s): 0295-1062-13
  • Packager: Denison Pharmaceuticals, Inc.
  • 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 January 1, 2017

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

  • 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

    38-62 lbs.......1 tsp

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

    88-112 lbs.....2 tsps

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

    138-162 lbs...3 tsps

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

    over187 lbs....4 tsps

  • Other information

    • read package insert carefully before using
    • if signs of pinworm 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, sodium carboxymethylcellulose, sodium citrate, sorbitol solution

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Cara Incorporated

    333 Strawberry Field Road

    Warwick, RI 02886

    www.caraincorporated.com

    Made in U.S.A. with foreign and domestic ingredients.

  • Cara PinAway

    NDC 70309-080-02

    PYRANTEL PAMOATE

    (PYRANTEL BASE 50 mg / mL)

    PINWORM TREATMENT

    Treats Ages 2 to Adult

    • Full prescription strength
    • Single dose effectiveness
    • Sugar-free caramel-flavored liquid
    • Measuring cup included

    2 FL OZ (60 mL)

    Cara Pin away

  • INGREDIENTS AND APPEARANCE
    PINAWAY 
    pyrantel pamoate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1062
    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)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCARAMELImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-1062-131 in 1 BOX01/01/2017
    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 finalpart357B01/01/2017
    Labeler - Denison Pharmaceuticals, Inc. (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, Inc.001207208MANUFACTURE(0295-1062)