FDA.reportPublic FDA data

BRONCOCHEM

Manufacturer
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Effective date
2024-04-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:17

Label at a glance#

ProductBRONCOCHEM MAXIMUM COUGH NIGHT
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PYRILAMINE MALEATE
Label structure12 sections

Indications and uses

Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough.

Dosage and administration

Do not exceed 4 doses in a 24 hour period. Adult and children 12 years and older: (5 or 10 mL) 3 times a day. Children between 6 to 12 years old: (2.5 mL) 3 times a day.

Label contents#

Full prescribing information#

Warnings 

WARNINGS SECTION

The following side effects may occur, nausea, vomiting, dizziness, headache, or nervousness may occur, if any of these effects last or worsen, contact your doctor or pharmacist immediately.  Stop using this medicine and tell your doctor right away if you have dizziness, nervousness, or trouble sleeping. 

OTC-PURPOSE SECTION

OTC - PURPOSE SECTION

Antitussive

Antihistamine

OTC - Active Ingredient Section

Dextromethorphan HBr

Mepyramine maleate

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough.

Do Not Use

OTC - DO NOT USE SECTION

Stop using this medicine and contact your doctor right away if any of these unlikely but serious side effects occur, fast and irregular heartbeat, mental mood changes such as confusion, hallucinations, nervousness, seizures, tremor, problems with to pee.

If you are taking any monoamine oxidase inhibitor (MAOI), or two weeks after stopping them (certain medications for depression or psycological conditions may contain them).  If you are not sure if your prescription contains an MAOI, coinsult a professional of health before taking this product.

Ask a doctor/pharmacist 

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if yoy have

Liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland, cough that occurs with too much phlegm (mucus), presistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Symptoms last more than 7 days, symptoms worsen or come back, you develop a headache that wont go away, fever, or skin rash.  If pregnant or breast-feeding ask a health professional before use.

Keep Out of the Reach of Children 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional help or go to poison control center immediately.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Do not exceed 4 doses in a 24 hour period.

Adult and children 12 years and older: (5 or 10 mL) 3 times a day.

Children between 6 to 12 years old: (2.5 mL) 3 times a day.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Sugar, Sodium Benzoate, FD&C Yellow #5, Orange flavor, MEthyl  paraben, Propyl paraben, ethyl alcohol 95%, Sorbitol 70%, Purified water.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Broncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BroncochemMaximumCoughNight_BoxProductionFile_v3 (002)-01.jpgBroncochemMaximumCoughNight_BoxProductionFile_v3 (002)-01.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2679777dextromethorphan hydrobromide 15 MG / pyrilamine maleate 6 MG in 5 mL Oral SolutionPSN3
2679777dextromethorphan hydrobromide 3 MG/ML / pyrilamine maleate 1.2 MG/ML Oral SolutionSCD3
2679777dextromethorphan hydrobromide 15 MG / pyrilamine maleate 6 MG per 5 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-035-80BRONCOCHEMMAXIMUM COUGH NIGHT120 mL in 1 BOTTLE, PLASTICSYRUP1203
65131-035-80BRONCOCHEMMAXIMUM COUGH NIGHT1 in 1 BOXSYRUP13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-035BRONCOCHEM MAXIMUM COUGH NIGHT (DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]3Current NDC, 2 package rows20240423_1a3ed214-e09b-4266-b68b-39e7c3127d26.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65131-03565131-035-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB
SUGARCANE81H2R5AOH3IACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ORANGE OILAKN3KSD11BIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
ALCOHOL 95%7528N5H79BIACT
SORBITOL SOLUTION 70%8KW3E207O2IACT
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 NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRL1a3ed214-e09b-4266-b68b-39e7c3127d262024-04-22WarningsExact identifier
ndc (package): 65131-035-80
ndc (product): 65131-035
ndc11 (package): 65131003580
spl id: 5c804db7-1a93-4b7c-9c07-11cd3e80e246
spl set id: 1a3ed214-e09b-4266-b68b-39e7c3127d26

Reported adverse events (FAERS/openFDA)#

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