G-tron
FDA Label NDC 52083-678

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 (NDC 52083-678). 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, warnings, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients (in each 5 mL tsp)                    Purpose

Dextromethorphan HBr, 15 mg............................Cough Suppressant

Guaifenesin, 350 mg..............................................Expectorant

Phenylephrine HCl, 10 mg................................Nasal decongestant



Otc - Purpose

Uses
  • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
  • temporarily relieves nasal congestion due to a cold

Warnings


Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Do Not Use


Ask a doctor before use if you have
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

    • When using this product do not use more than directed.

    Stop use and ask a doctor if
    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition.

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, get medical help or contact a Poison Control Center right away.


Directions

do not take more than 6 doses in any 24-hour period

EVERY 4 HOURS

  • Adults and Children 12 years of age and older: 5 mL (1 tsp)
  • Children 6 to under 12 years of age: (2.5 mL (1/2 tsp)
  • Children under 6 years of age: Consult physician

Indications & Usage


Other information

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

Store at controlled room temperature 15-30°C (59-86°F).

Avoid excessive heat and humidity.

Inactive Ingredient


Inactive ingredients Citric acid, flavor, hydroxyethyl cellulose, methyl paraben, potassium citrate, polyethylene glycol, propyl paraben, purified water, sorbitol and sucralose.

Otc - Questions

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917.
Tel: (787) 767-2072 / www.kramernovis.com

Principal Display Panel

G-TRON® PED

COUGH SUPPRESSANT

EXPECTORANT

NASAL DECONGESTANT

Contains the same active ingredients as Broncotron® PED

SUGAR FREE

DYE FREE

ALCOHOL FREE

GRAPE FLAVOR

16 Fl. Oz. (474 mL)

KRAMER-NOVIS

Kramer-supress-pe (G Tron)

Kramer-supress-pe (G Tron)

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