Goyescas Broncovac 1

Manufacturer
GOYESCAS OF FLA
Effective date
2015-10-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:20

Label at a glance#

ProductGoyescas Broncovac 1 Cough and Cold
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients: Purpose

(in each 5 ml. tsp)

Dextromethorphan HBr USP 10mg Cough Suppresant

Guaifenesin USP 50mg Expectorant

Phenylephrine HCI USP 5mg Nasal Decongestant

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions:

Dose as follows or as directed by a doctor. For adults and children 12 years of age and older, 1 tablespoonful every 6 hours. For children 6 to under 12 years of age, 1 teaspoonful every 6 hours. For children under 6 years of age, consult a Physician.

Warnings

WARNINGS SECTION

Warnings:

Do not use if you are now taking certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease (MAOI) or for two (2) weeks after stopping (MAOI) drugs. Stop and ask a doctor if cough lasts more than 7 days, if cough comes back or occurs with fever, rash or headache that lasts. Ask a doctor if you are pregnant or breast-feeding. Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center Immediately.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Althea F.E, Caramel Color, Citric Acid, FD&C Red #40, Flavor, Glycerin, Licorice Root F.E, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tolu F.E, Wild Cherry F.E and sucrose.

Use

INDICATIONS & USAGE SECTION

USE:

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves these symptoms occurring with a cold, nasal congestion, cough due to minor throat and bronchial irritation.

Purpose

OTC - PURPOSE SECTION

Active Ingredients: Purpose

(in each 5 ml. tsp)

Dextromethorphan HBr USP 10mg Cough Suppresant

Guaifenesin USP 50mg Expectorant

Phenylephrine HCI USP 5mg Nasal Decongestant

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings:

Do not use if you are now taking certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease (MAOI) or for two (2) weeks after stopping (MAOI) drugs. Stop and ask a doctor if cough lasts more than 7 days, if cough comes back or occurs with fever, rash or headache that lasts. Ask a doctor if you are pregnant or breast-feeding. Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center Immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredients: Purpose

(in each 5 ml. tsp)

Dextromethorphan HBr USP 10mg Cough Suppresant

Guaifenesin USP 50mg Expectorant

Phenylephrine HCI USP 5mg Nasal Decongestant

USE:

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves these symptoms occurring with a cold, nasal congestion, cough due to minor throat and bronchial irritation.

Warnings:

Do not use if you are now taking certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease (MAOI) or for two (2) weeks after stopping (MAOI) drugs. Stop and ask a doctor if cough lasts more than 7 days, if cough comes back or occurs with fever, rash or headache that lasts. Ask a doctor if you are pregnant or breast-feeding. Keep out of reach children. In case of overdose get medical help or contact a Poison Control Center Immediately.

Directions:

Dose as follows or as directed by a doctor. For adults and children 12 years of age and older, 1 tablespoonful every 6 hours. For children 6 to under 12 years of age, 1 teaspoonful every 6 hours. For children under 6 years of age, consult a Physician.

Inactive Ingredients:

Althea F.E, Caramel Color, Citric Acid, FD&C Red #40, Flavor, Glycerin, Licorice Root F.E, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tolu F.E, Wild Cherry F.E and sucrose.

CartonCarton

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1726414dextromethorphan HBr 10 MG / guaiFENesin 50 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN1
1726414dextromethorphan hydrobromide 2 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD1
1726414dextromethorphan hydrobromide 10 MG / guaifenesin 50 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSY1
1726414dextromethorphan hydrobromide 30 MG / guaifenesin 150 MG / phenylephrine hydrochloride 15 MG per 15 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11856-0016-12020-01-31C16284748780-19d75b9d0-267d-f424-e053-dadaa90a57ce227cde7b-bd96-27aa-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11856-0016-1Goyescas Broncovac 1Cough and Cold177 mL in 1 BOTTLELIQUID1771
11856-0016-1Goyescas Broncovac 1Cough and Cold1 in 1 BOXLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11856-0016GOYESCAS BRONCOVAC 1 COUGH AND COLD (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [GOYESCAS OF FLA]1Legacy NDC, 2 package rows20151213_227cde7b-bd96-27aa-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11856-001611856-0016-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
227cde7b-bd97-27aa-e054-00144ff8d46c227cde7b-bd96-27aa-e054-00144ff8d46c2015-10-19WarningsExact identifier
spl id: 227cde7b-bd97-27aa-e054-00144ff8d46c
spl set id: 227cde7b-bd96-27aa-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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