G-tron Pediatric Drops
FDA Label NDC 52083-679

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product G-tron Pediatric Drops (NDC 52083-679). 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 ingredients, purpose, otc - keep out of reach of children, uses, warnings, directions, other information, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Dextromethorphan HBr,5 mg
Guaifenesin, 100 mg
Phenylephrine HCL 2.5 mg

Purpose

Antitussive

Expectorant

Nasal Decongestant

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Uses

Non-narcotic cough suppressant which temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold • calms the cough control center and relieves coughing • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves nasal congestion due to the common cold • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

Warnings

Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.

Directions

Do not exceed 6 doses in any 24-hour period, or as directed by physician. Children 6 to under 12 years of age • 2 mL every 4 hours. Children 2 to under 6 years of age, ask a doctor.

Other Information

  • Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Avoid excessive heat and humidity.

Other

Manufactured in the USA for Kramer -Novis, San Juan, PR 00917.

Tel: (787)767-2072. www.kramernovis.com

* Broncotron® PED Drops is a registered trademark of Seyer Pharmatec.
This product is not manufactured, distributed or marketed by Seyer Pharmatec.

* Please review the disclaimer below.