FDA.reportPublic FDA data

BRONCOCHEM

Manufacturer
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Effective date
2025-03-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:57:13

Label at a glance#

ProductBRONCOCHEM MAXIMUM COUGH KIDS
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections

Indications and uses

Temporarily relieves coug due to minor throat and Bronchial irritation occurring with common cold.  Helps loosen phlegm (mucus) and dilute bronchial secretions to make cough more productive.

Dosage and administration

Take only as directed, for your convinience a dosage spoon is provided. Do not excees 6 doses in a 24 hour period Children from 6 to 12 years------15mL or cc every 4 hours Children from 2 to 6 years-------7.5mL or ccevery 4 hours Children under 2 years, ask your doctor

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

Do not Use

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) or two weeks after stopping the MAOI drug (certain drugs for depression, psychiatric or emotional conditions may contain MAOI), if you are uncertain whether your prescription contains MAOI ask a doctor or pharmacist before taking this product.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves coug due to minor throat and Bronchial irritation occurring with common cold.  Helps loosen phlegm (mucus) and dilute bronchial secretions to make cough more productive.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin........................100.00mg

Dextromethorphan HBr........10.00mg

Ask a doctor before use if your kid have

OTC - ASK DOCTOR SECTION

Cough that occurs with too much phlegm (mucus)

Persistent or chronic cough, asthma or emphysema

If your kid is allergic to any other component of this formula

Stop use and ask a doctor if

OTC - STOP USE SECTION

Symptoms last more than 5 days

Cough occurs with fever, rash or persistent headache, this could be signs of a serious condition

keep out of the reach od children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

Overdose Warnigs

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Take only as directed, for your convinience a dosage spoon is provided. Do not excees 6 doses in a 24 hour period

Children from 6 to 12 years------15mL or cc every 4 hours

Children from 2 to 6 years-------7.5mL or ccevery 4 hours

Children under 2 years, ask your doctor

Other Information

OTHER SAFETY INFORMATION

Store al 66-77

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Propylene glycol, Glycerin, Sorbitol 70%, Povidone, Sodium Citrate Dihydrate, Sodium Chloride,

Green color, White Vanilla Flavor, Aloe Vera, Methy Paraben USP, Propil Paraben USP. Peppermint Flavor, Bubble  Gum Flavor, Purified Water

Purpose

OTC - PURPOSE SECTION

Guaifenesin........................Expectorant

Dextromethorphan HBr.........Antotussive

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Etiq.Broncochem Maximum Cough Kids.jpgEtiq.Broncochem Maximum Cough Kids.jpgEtiq.Broncochem Maximum Cough Kids.jpgEtiq.Broncochem Maximum Cough Kids.jpg

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1298228dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral SolutionPSN4
1298228dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral SolutionSCD4
1298228dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral SolutionSY4
1298228dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 ML Oral SolutionSY4

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-180-98BRONCOCHEMMAXIMUM COUGH KIDS1 in 1 BOXSYRUP14
65131-180-98BRONCOCHEMMAXIMUM COUGH KIDS120 mL in 1 BOTTLE, PLASTICSYRUP1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-180BRONCOCHEM MAXIMUM COUGH KIDS (DEXTROMETHORPHAN HBR-GUAIFENESIN) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]4Current NDC, Legacy NDC, 2 package rows20250316_b0fd2f2f-5cc4-4813-8f99-c78fbe898656.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65131-18065131-180-98

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
DISODIUM HEDTAKME849MC7AIACT
POVIDONE K90RDH86HJV5ZIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM CHLORIDE451W47IQ8XIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
VANILLAQ74T35078HIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLPARABENA2I8C7HI9TIACT
PEPPERMINTV95R5KMY2BIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT

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 COUGH KIDSDEXTROMETHORPHAN HBR-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb0fd2f2f-5cc4-4813-8f99-c78fbe8986562025-03-13WarningsExact identifier
ndc (package): 65131-180-98
ndc (product): 65131-180
ndc11 (package): 65131018098
spl id: c63d515a-0755-4d0e-8aba-aca050df0456
spl set id: b0fd2f2f-5cc4-4813-8f99-c78fbe898656

Reported adverse events (FAERS/openFDA)#

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