BRONCOMAR MAXIMUN COUGH RELIEF- dextromethorphan hbr, guaifenesin liquid

Broncomar by

Drug Labeling and Warnings

Broncomar by is a Otc medication manufactured, distributed, or labeled by Dannso Corp./d.b.a. Essential Products, GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredients:(in each 10 ml.): Purpose
• Dextromethorphan Hydrobromide 30 mg ....................:

  Cough Suppressant

• Guaifenesin 200 mg.......................................................:

  Expectorant

PURPOSE

Uses:

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
• Temporarily 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 MAOI drug.
• If you do not know if your prescription drug contains MAOI as 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 beverage while taking this product.

Stop use and ask a doctor

• Nervousness, dizziness or sleeplessness occurs.
• Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be signserious condition.

ASK DOCTOR

Ask doctor before use if you have

• Cough that occurs with too much phlegm(mucus)
• Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

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 exceed 6 doses in any 24 hour period.

• AGE: DOSE
• Adults and Children 12 years and over: 10 ml (2 tsps) every 6 hours
• Children 6 to under 12 years of age: 5 ml (1 tsp) every 6 hours
• Children under 6 years of age: Do not use

INDICATIONS & USAGE

Other Information:

• Each 10 mls contains: sodium 4 mg
• Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
• Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.

Inactive Ingredient

Aloe Vera, Citric Acid, Disodium EDTA, FDC Red #40, Glycerin, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Purified Water, Sodium Benzoate, Sorbitol 70% USP, Sucralose.

Questions or Comments

Call Weekdays from 9:30 AM to 5PM EST at Tel 305-261-762

Distributed by

Essential Products Miami FL 33126

www.jjjdistributors.com

Made in U.S.A.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCOMAR  MAXIMUN COUGH RELIEF
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70242-103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70242-103-06	1 in 1 CARTON	01/01/2015
1		177 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2001

Labeler - Dannso Corp./d.b.a. Essential Products (059741071)

Registrant - Dannso Corp./d.b.a. Essential Products (059741071)

Establishment
Name	Address	ID/FEI	Business Operations
Dannso Corp./d.b.a. Essential Products		059741071	LABEL(70242-103)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(70242-103)