BRONCOCHEM

Manufacturer
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Effective date
2016-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:48:18

Label at a glance#

ProductBRONCOCHEM MAXIMUM COUGH
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

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 F...

Label contents#

Full prescribing information#

Warning Secction

WARNINGS SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin

Dextromethorphan HBr

Purpose

OTC - PURPOSE SECTION

Expectorant

Antitussive

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Indications and Usage

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionBMCUSABOXimage descriptionBMCUSABOX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234473dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN3
1234473dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
1234473dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-091-08BRONCOCHEMMAXIMUM COUGH120 mL in 1 BOTTLE, PLASTICSYRUP1203
65131-091-08BRONCOCHEMMAXIMUM COUGH1 in 1 BOXSYRUP13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-091BRONCOCHEM MAXIMUM COUGH (DEXTROMETHORPHAN HBR-GYAIFENESIN) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]3Current NDC, Legacy NDC, 2 package rows20161230_8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65131-09165131-091-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL8aa32b2a-a8be-4f8d-9b1f-eb007bff8e652016-12-19WarningsExact identifier
ndc (package): 65131-091-08
ndc (product): 65131-091
ndc11 (package): 65131009108
spl id: b4e75d5f-2f1c-4ea0-84f2-705fd4631199
spl set id: 8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.