BRONCOCHEM MAXIMUM COUGH- dextromethorphan hbr-gyaifenesin syrup 
LABORATORIO MAGNACHEM INTERNATIONAL SRL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BRONCOCHEM MAXIMUM COUGH

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

image descriptionBMCUSABOX

BRONCOCHEM  MAXIMUM COUGH
dextromethorphan hbr-gyaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-091
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65131-091-081 in 1 BOX12/30/2016
1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/30/2016
Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIO MAGNACHEM INTERNATIONAL SRL871446100manufacture(65131-091)

Revised: 12/2016
Document Id: b4e75d5f-2f1c-4ea0-84f2-705fd4631199
Set id: 8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65
Version: 3
Effective Time: 20161219
 
LABORATORIO MAGNACHEM INTERNATIONAL SRL