PINAWAY- pyrantel pamoate suspension 
Denison Pharmaceuticals, Inc.

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.

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PIN-AWAY

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 a doctor before use if

  • you're pregnant
  • have liver disease

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. 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

  • 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

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

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)

Revised: 1/2017
 
Denison Pharmaceuticals, Inc.