BRONCOCHEM MAXIMUM COUGH- dextromethorphan hbr-gyaifenesin syrup

BRONCOCHEM by

Drug Labeling and Warnings

BRONCOCHEM by is a Otc medication manufactured, distributed, or labeled by LABORATORIO MAGNACHEM INTERNATIONAL SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warning Secction

Do not take this product for persitent or chronic cough such as occurs with smoking, asthma, or emphysema or if cough is accompainied with excessive phlegm (mucus) unless directed by a doctor.  Persistent cough may be the sign of a serious condition.  Stop use and dask a doctor if symptoms persist or last more than 5 days (children) or 7 days (adults), tends to recur, is accompained or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor.  Do not take this product if you are hypersensitive to any of the ingredients.  As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.  Avoid alcoholic beverages while taking this product.

Active Ingredients

Guaifenesin

Dextromethorphan HBr

Purpose

Expectorant

Antitussive

Keep out of the reach of children

In case of accidental overdose, seek professional assistance or contact a poison control center immediately

Indications and Usage

Temporarily relieves cough due to minor throat and bronchial irritation occuring with common cold.

Helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive.

This new formulation with aloe results a natural cleanser, penetrates tissue, bactericidal, viruscidal, and fungicidal, enhances normal cell proliferation and moisturizes tissues (this statements are not yet evaluated by the Food and Drugs Administration "FDA")

Broncochem Maximum Cough has not drowsiness effect.

Work in chest congestion, its specially formulated for children and adults.

Dossage and Administration

Do not exceed 6 doses in a 24 hour period

Adults and children 12 years and over: (10mL or cc) every 4 hours

Children 6 years up to 12 years: (5mL or cc) every 4 hours

Drug Interactions Section

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI), (certain drugs for depression, psychiatric or emotional conditions or Parkinsons disease), or 2 weeks after stopping the MAOI drug.  Id you are uncertain ehether your prescription drug contains an MAOI, consult a health professional before taking this product

Inactive Ingredient Section

Aloe Vera, Ammonium Glycyrrhizinate, Citric Acid, Disodium HEDTA, Glacial Acetic Acid, Strawberry flavor, Propylene Glycol, Purified Water, FD&C Red 40, Sodium Benzoate, Sodium Chloride, Sodium Saccharin, Sorbitol, Carboxymethylcellulose sodium, Total Sodium content: 12mg (in 10mL or cc)

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCOCHEM  MAXIMUM COUGH
dextromethorphan hbr-gyaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65131-091
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	4 mg  in 10 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	20 mg  in 10 mL
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)	6.8 mg  in 10 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	12 mg  in 10 mL
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.508 mg  in 10 mL
DISODIUM HEDTA (UNII: KME849MC7A)	5 mg  in 10 mL
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)	20 mg  in 10 mL
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	30 mg  in 10 mL
ACETIC ACID (UNII: Q40Q9N063P)	0.016 mL  in 10 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	1.6 mL  in 10 mL
RASPBERRY (UNII: 4N14V5R27W)	0.04 mL  in 10 mL
SORBITOL (UNII: 506T60A25R)	2 mL  in 10 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	20 mg  in 10 mL
WATER (UNII: 059QF0KO0R)	10 mL  in 10 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65131-091-08	1 in 1 BOX	12/30/2016
1		120 mL in 1 BOTTLE, PLASTIC; 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	12/30/2016

Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)

Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIO MAGNACHEM INTERNATIONAL SRL		871446100	manufacture(65131-091)