Broncomar

Manufacturer
Gadal Laboratories Inc
Effective date
2014-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:32

Label at a glance#

ProductBroncomar SF
Active ingredientGUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acvtive ingredients: (in each 5ml)              Purpose

Guaifenesin 100 mg ................................... Expectorant

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.

WARNINGS SECTION

Warnings

Do not exceed recommended dosage

OTC - DO NOT USE SECTION

Do not use

  • if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor

Ask the doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

OTC - STOP USE SECTION

Stop use and ask the doctor if

  • Nervoisness, dizziness or sleeplessness occurs.
  • Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Do not take more than 6 doses in any 24-hour period
  • Shake well before use

Age                                                                        Dose

Adults and children 12 years and over           10 mL (2 tsps) every 4 hours

Children 6 to under 12 years of age.               5 mL (1 tsps) every 4 hours

Children under 6 years of age                       Do not use

INACTIVE INGREDIENT SECTION

Inactive ingredients

Blue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, glycerin, gold seal root, honey flavor, horehound herb, licorice root, menthol, mullein, myrrh, potassium sorbate, slippery elm bark, sodium benzoate, propylene glycol, water, sodium chloride, sucralose, wild cherry bark and zinc sulfate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BroncomarSFBroncomarSF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1540024Broncomar SF Expectorant 100 MG in 5 mL Oral SolutionPSN1
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN1
1540024guaifenesin 20 MG/ML Oral Solution [Broncomar Expectorant]SBD1
310604guaifenesin 20 MG/ML Oral SolutionSCD1
1540024Broncomar SF Expectorant 100 MG per 5 ML Oral SolutionSY1
310604guaifenesin 100 MG per 5 ML Oral SolutionSY1
310604guaifenesin 100 MG per 5 ML Oral SyrupSY1
310604guaifenesin 200 MG per 10 ML Oral SolutionSY1
310604guaifenesin 300 MG per 15 ML Oral SolutionSY1
310604guaifenesin 400 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53113-218-062019-11-27C16284748780-19855e2a2-33d2-60a7-e053-dbdaa90a05bd01bae271-502b-4345-b114-0072c39b4dba

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53113-218-06BroncomarSF177 mL in 1 BOTTLELIQUID1771
53113-218-06BroncomarSF1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53113-218BRONCOMAR SF (GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]1Legacy NDC, 2 package rows20140613_01bae271-502b-4345-b114-0072c39b4dba.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
GUAIFENESINACTIVE MOIETY495W7451VQ1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEH1
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DX1
EUCALYPTUS CAMALDULENSIS LEAF OILINACTIVE INGREDIENTSN6D1J15I61
GINKGO BILOBA WHOLEINACTIVE INGREDIENT660486U6OI1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JV1
HOREHOUNDINACTIVE INGREDIENTK08036XEJV1
LICORICEINACTIVE INGREDIENT61ZBX548831
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
MULLEIN LEAFINACTIVE INGREDIENT9936O846LI1
MYRRHINACTIVE INGREDIENTJC71GJ1F3L1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HA1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8Q1
WATERINACTIVE INGREDIENT059QF0KO0R1
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TB1

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
53113-21853113-218-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 452 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOZENGE / TRANSMUCOSAL44 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / TOPICAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL11 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION, CONCENTRATE / INTRAVENOUS60 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAPERITONEAL0.54 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVASCULARNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRALESIONAL13 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM / BUCCAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / PERINEURAL0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AJELLY / NASAL32.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SPRAY, METERED / NASAL0.06 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / OPHTHALMIC0.08 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAMUSCULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / AURICULAR (OTIC)18 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / TOPICAL0.18 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATUMOR1.2 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVESICAL351 mgExact identifier — unii candidate
134 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSHAMPOO / TOPICAL0.07 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / RETROBULBAR648 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates

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
1f890f7c-0ae0-4746-ad5e-de73ba50380101bae271-502b-4345-b114-0072c39b4dba2014-06-12WarningsExact identifier
spl id: 1f890f7c-0ae0-4746-ad5e-de73ba503801
spl set id: 01bae271-502b-4345-b114-0072c39b4dba

Reported adverse events (FAERS/openFDA)#

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