Otc - Active Ingredient
ACTIVE INGREDIENTS
PYRANTEL PAMOATE 144 MG (equivalent to 50 mg pyrantel base)
Parasitol Suspension
FDA Label NDC 53145-101
8 label sections · Submitted to the FDA by Menper Distributors Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors Inc. for the product Parasitol (NDC 53145-101). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE
Pinworm treatment
Indications & Usage
USES
FOR THE TREATMENT OF PINWORMS.
Warnings
WARNINGS
Do not Exceed recommended usage
Whenm using this product abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist consult a 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.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, seek medical attention or contact a Poison Control Center Immediately.
Dosage & Administration
Directions
Read package insert carefully before taking this medication. Take only according to directions and do not exceed the recommended dosage unless direct by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless direct 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 treatmen, consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor.
| Weight | Single Dose |
| Less than 25 pounds or under 2 years of age | Do not use unless directed by a doctor |
| 25 to 37 pounds | 1/2 teaspoonful (2.5 mL) |
| 38 to 62 pounds | 1 teaspoonful (5 mL) |
| 63 to 87 pounds | 1 1/2 teaspoonfuls (7.5 mL) |
| 88 to 112 pounds | 2 teaspoonfuls (10 mL) |
| 113 to 137 pounds | 2 1/2 teaspoonfuls (12.5 mL) |
| 138 to 162 pounds | 3 teaspoonfuls (15 mL) |
| 163 to 187 pounds | 3 1/2 teaspoonfuls (17.5 mL) |
| 188 pounds and over | 4 teaspoonfuls (20 mL) |
Shake well before use. This product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during, or after medication.
Inactive Ingredient
INACTIVE INGREDIENTS
acesulfame potassium, cherry flavor, citric acid, glycerin, methylparaben, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium bezoate, sodium carboximethylcellulose, sodium citrate, sorbitol, water, xanthan gum
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