Label: PRONTO PLUS- pyrantel pamoate liquid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated November 10, 2010
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each ½ TSP)
When using this product abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur. If any of these conditions persist, consult a doctor.
- 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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 59 mL Carton
FULL PRESCRIPTION STRENGTH
Pyrantel Pamoate Suspension
Doctor Recommended Ingredient
- Eliminates Pinworms with One Dose
Relieves Itching and Irritation
- Child Resistant Cap
Great Cherry Taste
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.
INGREDIENTS AND APPEARANCE
PRONTO PLUS PINWORM TREATMENT
pyrantel pamoate liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-240 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrantel pamoate (UNII: 81BK194Z5M) (Pyrantel - UNII:4QIH0N49E7) Pyrantel pamoate 5 mL in 250 mL Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) magnesium aluminum silicate (UNII: 6M3P64V0NC) povidone (UNII: FZ989GH94E) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sodium citrate (UNII: 1Q73Q2JULR) saccharin sodium (UNII: SB8ZUX40TY) sorbitol (UNII: 506T60A25R) cyclomethicone 6 (UNII: XHK3U310BA) Product Characteristics Color WHITE Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-240-24 24 in 1 CASE 1 1 in 1 CARTON 1 59 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part357B 09/20/2010 Labeler - Insight Pharmaceuticals LLC (176792315)