Active Ingredient (In Each 1 Ml)
Pyrantel pamoate 144 mg
(equivalent to 50 mg pyrantel base)
Pinaway
FDA Label NDC 70309-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cara, Incorporated for the product Pinaway (NDC 70309-080). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 1 ml), purpose, use, warnings, otc - ask doctor, otc - when using, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pinworm treatment
Use
for the treatment of pinworms.
Warnings
Do not exceed recommended dosage.
Otc - Ask Doctor
Ask a doctor before use if
- you're pregnant
- have liver disease
Otc - 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.
Otc - 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
Other
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)
* Please review the disclaimer below.
