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

G-TRON PEDIATRIC DROPS by

Drug Labeling and Warnings

G-TRON PEDIATRIC DROPS by is a Otc medication manufactured, distributed, or labeled by KRAMER NOVIS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

Manufactured in the USA for Kramer -Novis, San Juan, PR 00917.

Tel: (787)767-2072. www.kramernovis.com

SPL UNCLASSIFIED SECTION

* Broncotron® PED Drops is a registered trademark of Seyer Pharmatec.
This product is not manufactured, distributed or marketed by Seyer Pharmatec.

Packaging

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-679
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-679-01	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/09/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/09/2014

Labeler - KRAMER NOVIS (090158395)

Registrant - KRAMER NOVIS (090158395)