Active Ingredient
Active Ingredient (in each 1 ml) Purpose
| Active Ingredient (in each 1 ml) | Purpose |
| PYRANTEL PAMOATE | Pinworm Treatment |
Parasitexx
FDA Label NDC 70242-134
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dannso Corp./d.b.a. Essential Products for the product Parasitexx (NDC 70242-134). 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, inactive ingredient, dosage, uses, warnings, otc - ask doctor, otc - pregnancy or breast feeding, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
acesulfame potassium, cherry flavor, citric acid, glycerin, polysorbate 80, potassium sorbate, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol, water, xanthan gum.
Dosage
Directions Read package insert careful before taking this medication. Take only according to directions and do not exceed the recommended dosage unless directed by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless directed by a doctor. 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, or pinworms are still present after treatment, consult a doctor.
| Less than 26 pounds or under 2 years of age | Do not use unless directed by a doctor |
| 25 to 37 pounds | ½ teaspoonful (2.5 ml) |
| 38 to 62 pounds | 1 teaspoonful (5 ml) |
| 63 to 87 pounds | 1 ½ teaspoonfuls (7.5 ml) |
| 88 to 112 pounds | 2 teaspoonfuls (10 ml) |
| 113 to 137 pounds | 2 ½ teaspoonfuls (12.5 ml) |
| 138 to 162 pounds | 3 teaspoonfuls (15 ml) |
| 163 to 187 pounds | 3 ½ teaspoonfuls (17.5 ml) |
| 188 pounds and over | 4 teaspoonfuls (20 ml) |
Shake well before use. This product can be taken any time of the day, with or without meals. It may be taken alone or with milk or juice. Use of a laxative is not necessary prior to, during, or after medication.
Uses
For the treatment of pinworms.
Warnings
Do not exceed recommended dosage. When using this product abdominal cramps, nausea, diarrhea. Headache, or dizziness sometimes occurs after taking this drug. If this condition persists consult doctor.
Otc - Ask Doctor
Ask a doctor before use if you have liver disease.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Indications & Usage
Uses for the treatment of pinworns
Keep Out Of Reach Of Children.
In case of accidental overdose, seek medical attention or contact a Poison Control Center immediately.
Other Information
Protect from excessive heat and freezing. Store at room temperature.
Tamper-Evident Feature: do not use if printed seal around bottle neck is torn, broken or missing.
Otc - Questions
Questions? 305-261-8762
Monday – Friday 9am to 5pm EST.
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