BRONCOCHEM

Manufacturer
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Effective date
2025-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:24

Label at a glance#

ProductBRONCOCHEM KIDS COLD AND FLU
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure14 sections

Indications and uses

Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat.

Dosage and administration

Take only as directed, for your convenience a dosage spoon is provided. Do not exceed 6 doses in a 24 hour period Children from 6 to 12 years-----10mL or cc every 4 hours Children under 6 years, ask your doctor

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take:

More than 4 doses in 24 hour, wich is the maximum daily amount for this product.

With other drugs containing acetaminophen.

Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly.

allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include:

Sking reddening, blisters, rash.  If sking reactions occurs, stop use and seek medical attention.

Uses

INDICATIONS & USAGE SECTION

Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen...................325.00mg

Guaifenesin........................200.00mg

Phenylephrine HCl..................10.00mg

Ask a doctor before use if your kid have

OTC - ASK DOCTOR SECTION

Liver disease

Persistent or chronic cough, asthma or emphysema

If your kid is allergic to acetaminophen or any other componet of this formula

Stop use and ask a doctor if

OTC - STOP USE SECTION

Symtoms last more than 5 days

Fever gets worst or last more than 3 days, or occurs with rash or headache that last, a persistent cough, this could be signs of a serious conditions

If your child is taking the bloood thinning drug warfarin

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 inmediately

Directions

DOSAGE & ADMINISTRATION SECTION

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

Children from 6 to 12 years-----10mL or cc every 4 hours

Children under 6 years, ask your doctor

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Propylene glycol, glycerin, Sorbitol USP, Sucralose, Citric acid, disodium Hedta, Povidone, Sodium citrate dihydrate, Sodium chloride, Honey, Propyl gallate, FD&C Red #40, Aloe Vera, Methylparaben USP, Propylparaben USP, Bubble Gum flavor, Raspberry flavor, Nat. Masking type #27872, Purified water.

Purose

OTC - PURPOSE SECTION

Acetaminophen...........Analgesic

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

Phenylephrine.............Decongestant

Package principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAJA BRONCOCHEM KIDS COLD & FLU.jpgCAJA BRONCOCHEM KIDS COLD & FLU.jpgCAJA BRONCOCHEM KIDS COLD & FLU.jpgCAJA BRONCOCHEM KIDS COLD & FLU.jpgCAJA BRONCOCHEM KIDS COLD & FLU.jpgCAJA BRONCOCHEM KIDS COLD & FLU.jpg

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Etiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpgEtiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpgEtiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpgEtiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpgEtiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpgEtiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2712156acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSN1
2712156acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD1
2712156acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSY1
2712156APAP 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-109-84BRONCOCHEMKIDS COLD AND FLU120 mL in 1 BOTTLE, PLASTICSYRUP1201
65131-109-84BRONCOCHEMKIDS COLD AND FLU1 in 1 BOXSYRUP11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-109BRONCOCHEM KIDS COLD AND FLU (ACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESIN) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1Current NDC, 2 package rows20250421_b6559fb9-2dea-49c0-a274-3e77741a0ffd.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65131-10965131-109-84

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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 COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb6559fb9-2dea-49c0-a274-3e77741a0ffd2025-03-23WarningsExact identifier
ndc (package): 65131-109-84
ndc (product): 65131-109
ndc11 (package): 65131010984
spl id: 32488b26-1b57-45d6-98de-a851aa111128
spl set id: b6559fb9-2dea-49c0-a274-3e77741a0ffd

Reported adverse events (FAERS/openFDA)#

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