BRONCOMAR DM- dextromethorphan hbr, guaifenesin liquid

Broncomar by

Drug Labeling and Warnings

Broncomar by is a Otc medication manufactured, distributed, or labeled by Gadal Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acvtive ingredients: (in each 5ml)              Purpose

Dextromethorphan HBr 10 mg ................... Cough Suppressant

Guaifenesin 100 mg ................................... Expectorant

PURPOSE

Purpose

Cough Suppressant

Expectorant

INDICATIONS & USAGE

Uses

• Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
• Teporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold

WARNINGS

Warnings

Do not exceed recommended dosage

DO NOT USE

Do not use

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI)( certain drugs for depression , psychiatric conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug.
• if you do not know if your prescription drug contains on MAOI ask your doctor or pharmacist before taking this product
• if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor
• avoid alcoholic beverages while you are taking this product

Ask the doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

STOP USE

Stop use and ask the doctor if

• Nervoisness, dizziness or sleeplessness occurs.
• Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign 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 overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Do not take more than 6 doses in any 24-hour period
• Shake well before use

Age                                                                        Dose

Adults and children 12 years and over           10 mL (2 tsps) every 4 hours

Children 6 to under 12 years of age.               5 mL (1 tsps) every 4 hours

Children under 6 years of age                       Do not use

INACTIVE INGREDIENT

Inactive ingredients

Blue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, gold seal root, honey, honey flavor, horehound herb, licorice root, menthol, mullein, myrrh, potassium sorbate, slippery elm bark, sodium benzoate, propylene glycol, water, sodium chloride, sucralose, wild cherry bark and zinc sulfate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCOMAR  DM
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-217
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
EUCALYPTUS CAMALDULENSIS LEAF OIL (UNII: SN6D1J15I6)
GINKGO BILOBA WHOLE (UNII: 660486U6OI)
GOLDENSEAL (UNII: ZW3Z11D0JV)
HONEY (UNII: Y9H1V576FH)
HOREHOUND (UNII: K08036XEJV)
LICORICE (UNII: 61ZBX54883)
MENTHOL (UNII: L7T10EIP3A)
MULLEIN LEAF (UNII: 9936O846LI)
MYRRH (UNII: JC71GJ1F3L)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
ZINC SULFATE (UNII: 89DS0H96TB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-217-06	1 in 1 CARTON
1		177 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2014

Labeler - Gadal Laboratories Inc (841305639)