G-tron Pediatric Drops

G-tron Pediatric Drops
SPL v2
SPL
SPL Set ID c3881560-a16d-492a-b2f3-032927cf890d
Route
NASAL
Published
Effective Date 2014-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Menthol Methylparaben Polyethylene Glycol 1000 Propylene Glycol Propylparaben Sodium Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-09-09

Description

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

Purpose

Antitussive Expectorant Nasal Decongestant


Medication Information

Purpose

Antitussive

Expectorant

Nasal Decongestant

Description

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

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

Section 42229-5

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

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

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

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

Warnings

Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.

Packaging

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.
Active Ingredients

Dextromethorphan HBr,5 mg

Guaifenesin, 100 mg

Phenylephrine HCL 2.5 mg


Structured Label Content

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

Section 42229-5 (42229-5)

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

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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

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

Purpose

Antitussive

Expectorant

Nasal Decongestant

Warnings

Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.

Packaging

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 (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.
Active Ingredients

Dextromethorphan HBr,5 mg

Guaifenesin, 100 mg

Phenylephrine HCL 2.5 mg


Advanced Ingredient Data


Raw Label Data

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