Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (15 mg) Guaifenesin (350 mg) Phenylephrine (10 mg)

Inactive Ingredients

Citric Acid Monohydrate Hydroxyethyl Cellulose (280 Mpa.s At 5%) Methylparaben Potassium Citrate Polyethylene Glycol, Unspecified Propylparaben Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2014-01-27

Medication Information

Warnings and Precautions

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.

Indications and Usage

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.

Description

Active Ingredients (in each 5 mL tsp) Purpose Dextromethorphan HBr, 15 mg............................Cough Suppressant Guaifenesin, 350 mg..............................................Expectorant Phenylephrine HCl, 10 mg................................Nasal decongestant

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 50570-1

Ask a doctor before use if you have

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.

When using this product do not use more than directed.

Stop use and ask a doctor if

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.

Section 51727-6

Inactive ingredients Citric acid, flavor, hydroxyethyl cellulose, methyl paraben, potassium citrate, polyethylene glycol, propyl paraben, purified water, sorbitol and sucralose.

Section 53413-1

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

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

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

Section 55106-9

Active Ingredients (in each 5 mL tsp) Purpose

Dextromethorphan HBr, 15 mg............................Cough Suppressant

Guaifenesin, 350 mg..............................................Expectorant

Phenylephrine HCl, 10 mg................................Nasal decongestant

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

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

Structured Label Content

Indications and Usage (34067-9)

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.

Warnings and Precautions (34071-1)

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.

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 50570-1 (50570-1)

Ask a doctor before use if you have

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.

When using this product do not use more than directed.

Stop use and ask a doctor if

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.

Section 51727-6 (51727-6)

Inactive ingredients Citric acid, flavor, hydroxyethyl cellulose, methyl paraben, potassium citrate, polyethylene glycol, propyl paraben, purified water, sorbitol and sucralose.

Section 53413-1 (53413-1)

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

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

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

Section 55106-9 (55106-9)

Active Ingredients (in each 5 mL tsp) Purpose

Dextromethorphan HBr, 15 mg............................Cough Suppressant

Guaifenesin, 350 mg..............................................Expectorant

Phenylephrine HCl, 10 mg................................Nasal decongestant

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

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "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.", "34071-1": "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.", "50565-1": "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.", "50570-1": "Ask a doctor before use if you have 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. When using this product do not use more than directed. Stop use and ask a doctor if 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.", "51727-6": "Inactive ingredients Citric acid, flavor, hydroxyethyl cellulose, methyl paraben, potassium citrate, polyethylene glycol, propyl paraben, purified water, sorbitol and sucralose.", "53413-1": "Manufactured in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072 / www.kramernovis.com", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Uses 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", "55106-9": "Active Ingredients (in each 5 mL tsp) Purpose Dextromethorphan HBr, 15 mg............................Cough Suppressant Guaifenesin, 350 mg..............................................Expectorant Phenylephrine HCl, 10 mg................................Nasal decongestant", "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", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information