BRONCO PULMONAR SYRUP- guaifenesin, dextromethrophan hbr liquid

Bronco Pulmonar Syrup by

Drug Labeling and Warnings

Bronco Pulmonar Syrup 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 irritation and nasal congestion as may occur with the common cold or inhaled irritants

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)
• TAMPER EVIDENT. Do not use this product if seal on bottle is torn, broken or missing.

INACTIVE INGREDIENT

Inactive ingredients Artificial Raspberry Flavor, Citric Acid, D&C red #33, Methylparaben, Propylene Glycol, Propylparaben , Purified Water, Sucrose

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCO PULMONAR SYRUP 
guaifenesin, dextromethrophan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-030
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: 53145-030-04	1 in 1 CARTON
1		120 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)