BRONCO SILEN-DM- dextromethorphan hydrobromide, guaifenesin solution 
Caribe Natural, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BRONCO SILEN-DM

Active Ingredients (in each 10mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough Suppressant

Expectorant

Uses

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

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.

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

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

Directions:

agedose
adults and children 12 years and over10 ml (2 teaspoonfuls) every 4 hours; not to exceed 6 doses (12 teaspoonfuls) in a 24 hour period.
children 6 to under 12 years5 ml (1 teaspoonful) every 4 hours; not to exceed 6 doses (6 teaspoonfuls) in a 24 hour period.
children under 6 yearsAsk a doctor

Other Information

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) BRONCO SILEN-DM

BRONCO SILEN-DM 
dextromethorphan hydrobromide, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59561-202
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorRED (Clear) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59561-202-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/05/2015
Labeler - Caribe Natural, LLC (624210480)
Registrant - Caribe Natural, LLC (624210480)

Revised: 11/2015
Document Id: e90ddf21-87ce-462b-8344-5a578b17d52c
Set id: baf96bf1-7e70-4f08-9514-6f0d4cde6d88
Version: 1
Effective Time: 20151105
 
Caribe Natural, LLC