BRONCOCHEM

Manufacturer
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Effective date
2016-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:18

Label at a glance#

ProductBRONCOCHEM EXPECTORANT II
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

Do not exceed 4 doses in a 24 hour period Adults and chuildren 12 years and over: (10mL or cc) using metered dosage spoon every 6 hours. Children 6 years up to 12 years: (5mL or cc) using metered dosage spoon every 6 hours

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlem (mucus).  Likewise if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, if nervousness, dizziness, or sleeplesness occur, discontinue use or consult a doctor, if symptoms do not improve within 7 days or are accompainied by fever, consult a doctor.  A persistent cough may be a sing of a serious condition. Stop use and ask a doctor if symptoms persist or last long that 5 days (children) or 7 days (adults), tend to return, arash, or persistent headache.  As with any drug, if you are pregnant or nursing a baby; seek the advice of a healh professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing Pseudoephedrine HCl, or if you are taking sedatives or trankilizers; it may increase the drowsiness effect.  Avoid alcoholic beverages while taking this product.  Use caution when driving a motor vehicle or operating machinery.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen

Chlorpheniramine Maleate

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Purpose

OTC - PURPOSE SECTION

Analgesic

Antihistaminic

Antotussive

Expectorant

Decongestant

Keep Out Of the Reach Of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistancve or contact a poison control center inmediately

Indications & Use

INDICATIONS & USAGE SECTION

Bronchial congestion

Irritation of the respiratory passages

Nasal congestion

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

Antitussive

Temporarilly relieves allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergic rhinitis

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Do not exceed 4 doses in a 24 hour period

Adults and chuildren 12 years and over: (10mL or cc) using metered dosage spoon every 6 hours.

Children 6 years up to 12 years: (5mL or cc) using metered dosage spoon every 6 hours

Drug Interaction Precautions

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 Parkinson`s disease), or 2 weeks after stopping the MAOI drug.  If you are uncertain whether your presciption drug contains an MAOI, consult a health professional before taking this product

Iactive Ingredient

INACTIVE INGREDIENT SECTION

Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BUSAIIBOXBUSAIIBOX

Iactive Ingredient

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1743369acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral SolutionPSN2
1743369acetaminophen 25 MG/ML / chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD2
1743369acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY2
1743369APAP 25 MG/ML / Chlorpheniramine Maleate 0.4 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-116-87BRONCOCHEMEXPECTORANT II1 in 1 BOXSYRUP12
65131-116-87BRONCOCHEMEXPECTORANT II120 mL in 1 BOTTLE, PLASTICSYRUP1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-116BRONCOCHEM EXPECTORANT II (ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCL) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]2Current NDC, Legacy NDC, 2 package rows20161230_d0426469-9dd1-4bd1-b81e-69d33187daa2.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65131-11665131-116-87

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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 EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLd0426469-9dd1-4bd1-b81e-69d33187daa22016-12-19WarningsExact identifier
ndc (package): 65131-116-87
ndc (product): 65131-116
ndc11 (package): 65131011687
spl id: 383c518a-2d0c-4346-894c-9e089094d612
spl set id: d0426469-9dd1-4bd1-b81e-69d33187daa2

Reported adverse events (FAERS/openFDA)#

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