BRONCO SILEN-DM- dextromethorphan hydrobromide, guaifenesin solution

BRONCO SILEN-DM by

Drug Labeling and Warnings

BRONCO SILEN-DM by is a Otc medication manufactured, distributed, or labeled by Caribe Natural, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each 10mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough Suppressant

Expectorant

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

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.

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

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.

DOSAGE & 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

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

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)

INGREDIENTS AND APPEARANCE

BRONCO SILEN-DM 
dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59561-202
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYETHYL CELLULOSE (6500 MPA.S AT 2%) (UNII: 2Q40985DRM)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED (Clear)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59561-202-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/05/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/05/2015

Labeler - Caribe Natural, LLC (624210480)

Registrant - Caribe Natural, LLC (624210480)