Bronco Silen-dm

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (20 mg) Guaifenesin (400 mg)

Inactive Ingredients

Citric Acid Monohydrate Fd&c Red No. 40 Hydroxyethyl Cellulose (6500 Mpa.s At 2%) Menthol, Unspecified Form Methylparaben Polyethylene Glycols Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2015-11-05

Medication Information

Purpose

Cough Suppressant

Expectorant

Dosage and Administration

Directions:

age	dose
adults and children 12 years and over	10 ml (2 teaspoonfuls) every 4 hours; not to exceed 6 doses (12 teaspoonfuls) in a 24 hour period.
children 6 to under 12 years	5 ml (1 teaspoonful) every 4 hours; not to exceed 6 doses (6 teaspoonfuls) in a 24 hour period.
children under 6 years	Ask a doctor

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses

temporarily relieves cough due to minor throat and bronchial irritation may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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 50566-9

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 53414-9

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

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 health professional before taking this product.

Questions:

Contact us Monday to Friday at (305) 256-1469 9:00am - 5:00pm EST.

Display Label

NDC 59561-202-04

GERMA

BRONCO-SILEN-DM

COUGH SUPPRESSANT

EXPECTORANT

Sugar FREE

Alcohol FREE

Non-Drowsy

New Improved Taste

Stronger than Leading Brands

Contents: 4 FL. OZ. (118 mL)

Other Information

Store at room temperature 15° - 30ºC (59º - 86ºF)

Inactive Ingredients

Cherry Flavor, Citric Acid, FD&C red no. 40, Hydroxyethyl Cellulose, Menthol, Methylparaben, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and Sucralose

Active Ingredients (in Each 10ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have

cough that occurs with to much phlegm (mucus)
cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Structured Label Content

Uses

temporarily relieves cough due to minor throat and bronchial irritation may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and Administration (34068-7)

Directions:

age	dose
adults and children 12 years and over	10 ml (2 teaspoonfuls) every 4 hours; not to exceed 6 doses (12 teaspoonfuls) in a 24 hour period.
children 6 to under 12 years	5 ml (1 teaspoonful) every 4 hours; not to exceed 6 doses (6 teaspoonfuls) in a 24 hour period.
children under 6 years	Ask a doctor

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 50566-9 (50566-9)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 53414-9 (53414-9)

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

Purpose

Cough Suppressant

Expectorant

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 health professional before taking this product.

Questions:

Contact us Monday to Friday at (305) 256-1469 9:00am - 5:00pm EST.

Display Label

NDC 59561-202-04

GERMA

BRONCO-SILEN-DM

COUGH SUPPRESSANT

EXPECTORANT

Sugar FREE

Alcohol FREE

Non-Drowsy

New Improved Taste

Stronger than Leading Brands

Contents: 4 FL. OZ. (118 mL)

Other Information

Store at room temperature 15° - 30ºC (59º - 86ºF)

Inactive Ingredients (Inactive ingredients)

Cherry Flavor, Citric Acid, FD&C red no. 40, Hydroxyethyl Cellulose, Menthol, Methylparaben, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and Sucralose

Active Ingredients (in Each 10ml) (Active Ingredients (in each 10mL))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

cough that occurs with to much phlegm (mucus)
cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves cough due to minor throat and bronchial irritation may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes", "34068-7": "Directions: age dose adults and children 12 years and over 10 ml (2 teaspoonfuls) every 4 hours; not to exceed 6 doses (12 teaspoonfuls) in a 24 hour period. children 6 to under 12 years 5 ml (1 teaspoonful) every 4 hours; not to exceed 6 doses (6 teaspoonfuls) in a 24 hour period. children under 6 years Ask a doctor", "50565-1": "Keep out of reach of children . In case of accidental overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Cough Suppressant Expectorant", "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 health professional before taking this product.", "Questions:": "Contact us Monday to Friday at (305) 256-1469 9:00am - 5:00pm EST.", "Display Label": "NDC 59561-202-04 GERMA BRONCO-SILEN-DM COUGH SUPPRESSANT EXPECTORANT Sugar FREE Alcohol FREE Non-Drowsy New Improved Taste Stronger than Leading Brands Contents: 4 FL. OZ. (118 mL)", "Other Information": "Store at room temperature 15° - 30ºC (59º - 86ºF)", "Inactive ingredients": "Cherry Flavor, Citric Acid, FD&C red no. 40, Hydroxyethyl Cellulose, Menthol, Methylparaben, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and Sucralose", "Active Ingredients (in each 10mL)": "Dextromethorphan HBr 20 mg Guaifenesin 400 mg", "Ask a doctor before use if you have": "cough that occurs with to much phlegm (mucus) cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information