BRONKISAN- guaifenesin, dextromethorphan hbr liquid

Bronkisan by

Drug Labeling and Warnings

Bronkisan by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each 5mL tsp)

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

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

PURPOSE

Expectorant

Cough Suppressant

INDICATIONS & USAGE

Uses

• temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.  

WARNINGS

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

Do not use:

• This product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
• 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

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.

DOSAGE & ADMINISTRATION

Directions

• Do not exceed 6 doses in 24 hours.

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 SAFETY INFORMATION

Other information

• store this product between 15°-30°C (59°-86°F)

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONKISAN 
guaifenesin, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-032
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-032-06	1 in 1 CARTON
1		180 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)