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G-TRON PEDIATRIC DROPS

Dosage form: solution/ drops
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 1mL, GUAIFENESIN 100mg in 1mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1mL
Labeler: KRAMER NOVIS
NDC Code: 52083-679

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.

G-TRON PEDIATRIC DROPS

Active Ingredients

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

Purpose

Antitussive

Expectorant

Nasal Decongestant

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 15º-30ºC (59º-86ºF).
  • Avoid excessive heat and humidity.

Citric acid, flavor, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution and sucralose.

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.

Packaging

G-TRON PEDIATRIC DROPS 
dextromethorphan hbr,guaifenesin,phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-679
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
MENTHOL 
METHYLPARABEN 
POLYETHYLENE GLYCOL 1000 
PROPYLENE GLYCOL 
PROPYLPARABEN SODIUM 
WATER 
SORBITOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorgrapeImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52083-679-0130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/09/2014
Labeler - KRAMER NOVIS (090158395)

Revised: 09/2014
 
KRAMER NOVIS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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