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  5. Label Information: G-tron Pediatric Drops

FDA Label for G-tron Pediatric Drops

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. OTHER
    9. PACKAGING

G-tron Pediatric Drops Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Novis. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.