Pronto Plus
FDA Label NDC 63736-240

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Pronto Plus (NDC 63736-240). 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 other, active ingredient (in each ½ tsp), purpose, use, otc - ask doctor, otc - when using, otc - keep out of reach of children, overdose warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each ½ Tsp)

→ Purpose

→ Use

→ Otc - Ask Doctor

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 59 Ml Carton

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