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G-TRON PED

Medically reviewed on January 29, 2018

Dosage form: solution
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg in 5mL, GUAIFENESIN 350mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 5mL
Labeler: Kramer Novis
NDC Code: 52083-678

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients (in each 5 mL tsp)                    Purpose

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

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

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



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

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.


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.


If pregnant or breast-feeding, ask a health professional before use.



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


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

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

G-TRON  PED
dextromethorphan hbr, guiafenesin, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-678
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN350 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%) 
METHYLPARABEN 
POTASSIUM CITRATE 
POLYETHYLENE GLYCOLS 
PROPYLPARABEN 
WATER 
SORBITOL 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:52083-678-16474 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2014
Labeler - Kramer Novis (090158395)

 
Kramer Novis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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