FDA.reportPublic FDA data

BRONCOCHEM

Manufacturer
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Effective date
2017-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:29

Label at a glance#

ProductBRONCOCHEM ALLERGY CONTROL
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

Nasal congestion, irritation of the upper respiratory passages, temporarily reduces allergy, swelling of nasal passages, sneezing, itching of the nose or throat, itchy watery eyes, allergic 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. Adults and Children from 12 years above 10mL or cc every 6 hours. Children from 6 to 12 years 5mL or cc every 6 hours. Children under 6 years, ask your doctor.

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

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 oharmacist before taking this product.

Uses

INDICATIONS & USAGE SECTION

Nasal congestion, irritation of the upper respiratory passages, temporarily reduces allergy, swelling of nasal passages, sneezing, itching of the nose or throat, itchy watery eyes, allergic rhinitis.

Active ingredients (in 10 mL or cc)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine Maleate.......4.00mg (antihistamine)

Phenylephrine HCl..................5.00mg (Decongestant)

Ask a doctor or Pharmacist if you

OTC - ASK DOCTOR/PHARMACIST SECTION

Are taking sedatives or tranquilizers

When Using this Product

OTC - WHEN USING SECTION

Excitability may occur, especially in children.

May cause marked drowsiness

Avoid alcoholic drinks

Alcohol, sedatives and tranquilizers may increase drowsiness

Be careful when driving or operating machinery

Stop Use and Ask a Doctor If

OTC - STOP USE SECTION

Nervousness, dizziness or sleeplessness occur.

Symptoms last more than five days.

If fever is presented that last more than 3 days or headache appers, this could be signs of a serious condition.

Keep Out of the Reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

If pregnant or breast-feeding, ask a doctor before taking this product.

Overdose warning

OVERDOSAGE SECTION

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

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.

Adults and Children from 12 years above 10mL or cc every 6 hours.

Children from 6 to 12 years 5mL or cc every 6 hours.

Children under 6 years, ask your doctor.

Other Information

OTHER SAFETY INFORMATION

Store at 66-77

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Propylene glycol, Glicerin, Sorbitol 70% USP, sucralose, Povidone, Sodium chloride, Aloe Vera, Metil paraben USP, Propil paraben USP, Propyl gallate, Citric acid, Sodium citrate dihydrate, EDTA disodium, Grape flavor, Purified water.

Questions

OTC - QUESTIONS SECTION

1-561-338-5221 or visit us at www.broncochem.com

Made in Dominican Republic by Laboratorio Magnachem International SRL to Global Corporation Inc. Boca Raton, Fl 33487

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAJA_BRONCOCHEM ALLERGY 120mL.jpgCAJA_BRONCOCHEM ALLERGY 120mL.jpg

PAKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ETIQ.BRONCOCHEM ALLERGY CONTROL.jpgETIQ.BRONCOCHEM ALLERGY CONTROL.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1876117chlorpheniramine maleate 0.4 MG/mL / phenylephrine HCl 1 MG/mL Oral SolutionPSN1
1876117chlorpheniramine maleate 0.4 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD1
1876117chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-098-47BRONCOCHEMALLERGY CONTROL1 in 1 BOXSYRUP11
65131-098-47BRONCOCHEMALLERGY CONTROL120 mL in 1 BOTTLE, PLASTICSYRUP1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-098BRONCOCHEM ALLERGY CONTROL (CHOLPHENIRAMINE MALEATE-PHENYLEPHRINE HCL) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1Current NDC, Legacy NDC, 2 package rows20170401_ec5a216c-6827-4de3-8683-ff04e726ff6f.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
65131-09865131-098-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
POVIDONE K90RDH86HJV5ZIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYL GALLATE8D4SNN7V92IACT
CITRIC ACID ACETATEDSO12WL7AUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
EDETATE SODIUMMP1J8420LUIACT
GRAPEFRUITO82C39RR8CIACT
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 ALLERGY CONTROLCHOLPHENIRAMINE MALEATE-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLec5a216c-6827-4de3-8683-ff04e726ff6f2017-03-14WarningsExact identifier
ndc (package): 65131-098-47
ndc (product): 65131-098
ndc11 (package): 65131009847
spl id: 8ddc705a-c6b4-4b03-8492-d2b00eaa4b88
spl set id: ec5a216c-6827-4de3-8683-ff04e726ff6f

Reported adverse events (FAERS/openFDA)#

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