Otc - Active Ingredient
ACTIVE INGREDIENTS
PYRANTEL PAMOATE 144 MG/ML
Parasitol Suspension
FDA Label NDC 53145-101
Full FDA labeling including 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 - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE
PARASITICIDE
Indications & Usage
USES
FOR THE TREATMENT OF PINWORMS.
Warnings
WARNINGS
ABDOMINAL CRAMPS, NAUSEA, VOMITING, DIARRHEA HEADACHES OR DIZZINESS SOMETIMES OCCUR AFTER TAKING THIS DRUG. IF ANY OF THOSE CONDITIONS PERSIST, CONSULT A DOCTOR. IF YOU ARE PREGNANT OR HAVE LIVER DISEASE, DO NOT TAKE THIS PRODUCT UNLESS DIRECTED BY A DOCTOR. PROTECT FROM EXCESSIVE HEAT AND FREEZING. SHAKE WELL.
STORE AT CONTROLLED ROOM TEMPERATURE.
READ WARNINGS AND PACKAGE INSERT CAREFULLY BEFORE TAKING THIS MEDICATION.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Dosage & Administration
DIRECTIONS
ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER AND CHILDREN 2 YEARS OF AGE TO UNDER TWELVE YEARS, ORAL DOSAGE IS A SINGLE DOSE OF 5MG OF PARASITOL PER POUND OR 11 MG PER KG OFBODY WEIGHT, NOT TO EXCEED 1 GM. TAKE ONLY ACCORDING TO DIRECTIONS AND DO NOT EXCEED RECOMMENDED DOSGE 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 HOUSEHOLD HAS PARSITES, THE ENTIRE HOUSEHOLD SHOULD BE TREATED UNLESS OTHERWISE ADVISED.
Inactive Ingredient
INACTIVE INGREDIENTS
PURIFIED WATER, SUCROSE, PROPYLENE GLYCOL, SODIUM CARBOXYMETHYLCELLULOSE, XANTHAN GUM, METHYLPARABEN, CHERRY FLAVOR AND PROPYLPARABEN
Package Label.Principal Display Panel
* Please review the disclaimer below.
