G-TRON

Kramer Novis

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Directions
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FULL PRESCRIBING INFORMATION

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

Purpose

• 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

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.

• 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.
  

• 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

Uses

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

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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 Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl SOLUTION Product Information Product Type Human otc drug label Item Code (Source) NDC:52083-678 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg Guaifenesin GUAIFENESIN 350 mg Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%) METHYLPARABEN POTASSIUM CITRATE POLYETHYLENE GLYCOLS PROPYLPARABEN water sorbitol Sucralose Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-678-16 474 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part341 2014-01-27