PINAWAY- pyrantel pamoate suspension

PinAway by

Drug Labeling and Warnings

PinAway by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

PINAWAY 
pyrantel pamoate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1062
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	144 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CARAMEL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1062-13	1 in 1 BOX	01/01/2017
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part357B	01/01/2017

Labeler - Denison Pharmaceuticals, Inc. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	MANUFACTURE(0295-1062)