Polyactil N
FDA Label NDC 69492-015

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Polimeros Y Servicios S.a. for the product Polyactil N (NDC 69492-015). 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 detail showing active ingredient from package, detail showing inactive ingredient from package, detail showing purpose within active ingredients from package, detail showing indications from pacage, detail shyowing instructions for use and named directions from package, detail showing dosage abd administration within directions from package, detail showing warnings from package, detail showing keep out of reach of children within warnings from package, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Detail Showing Active Ingredient From Package

Information shown both on container label and paclage

Drug fact active ingredients -.jpg

Detail Showing Inactive Ingredient From Package

Information shown both on cntainer label and package

Inactive ingredients-.jpg

Detail Showing Purpose Within Active Ingredients From Package

Information shown both on container label and package

Purpose .jpg

Detail Showing Indications From Pacage

Information shown both on container label and package

Indicationss.jpg

Image Description (Indicationss)

Image Description (Indicationss)

Detail Shyowing Instructions For Use And Named Directions From Package

Information shown both on container label and package

Drug Fast (continued).jpg

Detail Showing Dosage Abd Administration Within Directions From Package

Information shown both on container lable and package

Dosage and ad.jpg

Detail Showing Warnings From Package

Information shown both on container label and package

Drug Facts Warnings.jpg

Detail Showing Keep Out Of Reach Of Children Within Warnings From Package

nformation shown on package

Keep out of reach of chilfren.jpg

Detail Showing Questions From Package

Questions or comments.jpg

Detail Showing Other Safety Information From Package

Information shown both on container label and package

Other informations-.jpg

Representative Sample Image Of Carton/Container Label

General view of inner container label

Etiqueta de Polyactil - N Lunes 20 06 16.jpg

General view of box content of labeling

Polyactil - N Lunes 20 06 16.jpg

* Please review the disclaimer below.