BRONKISAN- guaifenesin, dextromethorphan hbr liquid 
Menper Distributors, Inc.

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.

----------

Active ingredients (in each 5mL tsp)

Guaifenesin 100 mg………………………………Expectorant

Dextromethorphan HBr 10 mg……………………Cough suppressant

Expectorant

Cough Suppressant

Uses

Warnings Do not exceed recommended dosage.

A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to reoccur, or is accompanied by fever, rash, or persistent headache, consult a doctor

Do not use:

Keep out of reach of children.

If you are pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

age                                                                              dose

Adults and children 2 teaspoonfuls (10 mL)

12 years of age and over....................................... every 4 hours

Children 6 to under 1 teaspoonful (5 mL)

12 years of age..................................................... every 4 hours

Children 2 to under 1/2 teaspoonful (2.5 mL)

6 years of age....................................................... every 4 hours

Children under 2 years of age.................................. consult your doctor

Other information

Inactive Ingredients Artificial raspberry flavor, citric acid, D&C red #33, glycerin, methylparaben, propylene glycol, propylparaben , purified water, sucrose

Bronkisan Label

BRONKISAN 
guaifenesin, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-032
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
RASPBERRY (UNII: 4N14V5R27W)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-032-061 in 1 CARTON
1180 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/21/2012
Labeler - Menper Distributors, Inc. (101947166)

Revised: 8/2013
Document Id: 63464087-a8dd-43b7-b81e-be9e9c8bf1ce
Set id: dea97228-14f4-4778-b899-5cfff599a4da
Version: 1
Effective Time: 20130829
 
Menper Distributors, Inc.