FDA Label for Pronto Plus Pinworm Treatment
View Indications, Usage & Precautions
Pronto Plus Pinworm Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749 © 2010 Insight Pharmaceuticals Corporation
Active Ingredient (In Each ½ Tsp)
Pyrantel pamoate 360 mg
(equivalent to 125mg / ½ TSP pyrantel base)
Purpose
Pinworm treatment
Use
for the treatment of pinworms
Otc - Ask Doctor
Ask a doctor before use if
- you are pregnant
- you have liver disease
Otc - When Using
When using this product abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur. If any of these conditions persist, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- read package insert carefully before using. Use only according to directions. Do not exceed the recommended dosage unless directed by a doctor.
- shake well before using
- adults and children 2 years of age and older: dose one time as a single dose; do not repeat treatment unless directed by a doctor.
- find the right dose on chart below. Use weight to dose.
- use enclosed dosing cup. Do not use with any other device.
- take any time of day, with or without meals. May be taken alone or with milk or fruit juice. Use of a laxative is not needed before, during, or after taking Pronto Plus.
- when one individual in a household has pinworms, the entire household should be treated unless otherwise advised. See Warnings
- if any worms other than pinworms are present before or after treatment, ask a doctor
- if any symptoms or pinworms are still present after treatment, ask a doctor
| Weight (lbs) | Single Dose (TSP) |
|---|---|
| Under 25 lbs or under 2 years | Ask a doctor |
| 25-37 | ½ |
| 38-62 | 1 |
| 63-87 | 1 ½ |
| 88-112 | 2 |
| 113-137 | 2 ½ |
| 138-162 | 3 |
| 163-187 | 3 ½ |
| 188 and over | 4 |
Other Information
The maximum dosage listed (4 TSP) contains 16 mg of sodium. Keep carton for full drug facts. Store at 15°C - 25°C (59°F - 77°F).
Inactive Ingredients
cherry flavor, citric acid, glycerin, lecithin, magnesium aluminum silicate, methylcellulose, povidone, purified water, simethicone, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
Questions?
Call 1-888-542-3546
www.prontoplus.com
Principal Display Panel - 59 Ml Carton
FULL PRESCRIPTION STRENGTH
PRONTO®
PLUS
Pyrantel Pamoate Suspension
Pinworm Treatment
Doctor Recommended Ingredient
- Eliminates Pinworms with One Dose
- Relieves Itching and Irritation
from Pinworms - Child Resistant Cap
Great Cherry Taste
Sugar Free
2 FL OZ (59 mL)
NEW FAMILY SIZE
Do not use if foil seal under bottle cap imprinted with
"Sealed for Your Protection" is broken or missing.
* Please review the disclaimer below.