G-TRON PED- dextromethorphan hbr, guiafenesin, phenylephrine hcl solution 
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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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


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

When using this product do not use more than directed.

Stop use and ask a doctor if


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


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

kramer-supress-pe
G-TRON  PED
dextromethorphan hbr, guiafenesin, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-678
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN350 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%) (UNII: B24JYI97VR)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-678-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product01/27/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2014
Labeler - Kramer Novis (090158395)

Revised: 9/2019
Document Id: 7d8d222b-b7a2-4165-b432-d400969ec490
Set id: 75cd3241-e571-4b50-b03a-1715dc747825
Version: 3
Effective Time: 20190916
 
Kramer Novis