G-TRON PEDIATRIC DROPS- dextromethorphan hbr,guaifenesin,phenylephrine hcl solution/ drops 
KRAMER NOVIS

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.

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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

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 Label

G-TRON PEDIATRIC DROPS 
dextromethorphan hbr,guaifenesin,phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-679
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorgrapeImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-679-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/09/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/09/2014
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)

Revised: 11/2019
Document Id: b60138fe-f319-4ed1-b13a-5ce5d0cbcce8
Set id: c3881560-a16d-492a-b2f3-032927cf890d
Version: 2
Effective Time: 20191113
 
KRAMER NOVIS