BRONCOCHEM

Manufacturer
LABORATORIO MAGANCEHM INTERNATIONAL SRL | LABORATORIO MAGNACHEM INTERNATIONAL SRL
Effective date
2017-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:42

Label at a glance#

ProductBRONCOCHEM KIDS ALLERGY CONTROL
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure14 sections

Indications and uses

Temporarily relieves cold symptoms, cough, helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive. Reduces allergic symptoms like runny nose and sneezing, irritated ans watery eyes, Itchy nose, Itchy throat, Allergy rhinitis

Dosage and administration

Take only as directed, for your convenience a dosage spoon is provided Do not exceed 4 doses in a 24-hour period Children from 6 to 12 years-----10mL or cc every 6 hours Children fron 2 to 6 years-------5mL or cc every 6 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 weks after stopping the MAOI drug (certain drugs for depression, psuchiatric or emotional conditions may contain MAOI), if you are uncertain whether your prescription contains MAOI ask a doctor or pharmacist before taking this product

active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr.......10.00mg

Chlorpheniramine maleate...2.00mg

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves cold symptoms, cough, helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive.

Reduces allergic symptoms like runny nose and sneezing, irritated ans watery eyes, Itchy nose, Itchy throat, Allergy rhinitis

Ask a doctor before use if your kid have

OTC - ASK DOCTOR SECTION

Cough with lots of phlegm

Chornic cough, asthma or emphysema

Respiratory problems

Chornic bronchitis

If your child is allergyc to another component of this formula

Stop use and ask a doctor if

OTC - STOP USE SECTION

Symptoms last more than 5 days

If your child feels dizziness, nervous or cannot sleep

If the cough present fever and headache, this could be signs of a serious conditions

If new symptoms occur

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

Overdose warning

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 convenience a dosage spoon is provided

Do not exceed 4 doses in a 24-hour period

Children from 6 to 12 years-----10mL or cc every 6 hours

Children fron 2 to 6 years-------5mL or cc every 6 hours

Children under 2 years, ask your doctor

Other information

OTHER SAFETY INFORMATION

Store at 66-77*F (20-25*C), do not use if security cap is altered or broken

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Propylene glycol, Gliceryn, Sorbitol 70%, Sucralose, Povidone, Sodium Chloride, Aloe vera, Methylparaben USP, Propylparaben USP, Ascorbic acid, Color Yellow #5, Dosodium Hedta, Orange flavor, Sodium hydroxide, Purified water

Purpose

OTC - PURPOSE SECTION

Dextromethorphan HBr------Antitussive

Chlorpheniramine maleate--Antihistamine

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BRONCOCHEM KIDS ALLERGY CONTROL BOX.jpgBRONCOCHEM KIDS ALLERGY CONTROL BOX.jpg

Package Label Principal display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Etiq.Broncochem Ninos Allery Control_Bottle Label.jpgEtiq.Broncochem Ninos Allery Control_Bottle Label.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
636568chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral SolutionPSN1
636568chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD1
636568chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG per 5 ML Oral SolutionSY1
636568chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-418-09BRONCOCHEMKIDS ALLERGY CONTROL1 in 1 BOXSYRUP11
65131-418-09BRONCOCHEMKIDS ALLERGY CONTROL120 mL in 1 BOTTLE, PLASTICSYRUP1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-418BRONCOCHEM KIDS ALLERGY CONTROL (CHLORPHENIRAMINE MALEATE-DEXTROMETHROPHAN HBR) SYRUP [LABORATORIO MAGANCEHM INTERNATIONAL SRL]1Current NDC, Legacy NDC, 2 package rows20170501_36574266-a6ca-443d-9e1d-85240aabe8a2.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
65131-41865131-418-09

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 KIDS ALLERGY CONTROLCHLORPHENIRAMINE MALEATE-DEXTROMETHROPHAN HBRLABORATORIO MAGANCEHM INTERNATIONAL SRL36574266-a6ca-443d-9e1d-85240aabe8a22017-04-10WarningsExact identifier
ndc (package): 65131-418-09
ndc (product): 65131-418
ndc11 (package): 65131041809
spl id: d42910c8-7859-41af-ae13-a7e442b6924f
spl set id: 36574266-a6ca-443d-9e1d-85240aabe8a2

Reported adverse events (FAERS/openFDA)#

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