FDA.reportPublic FDA data

Broncomar Expectorant

Manufacturer
Dannso Corp./d.b.a. Essential Products | All Pharma LLC
Effective date
2016-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:30:13

Label at a glance#

ProductBroncomar Expectorant SF
Active ingredientGUAIFENESIN
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:(in each 5 ml.)Purpose

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

Expectorant

OTC - PURPOSE SECTION

Uses:

  • Helps 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 - ASK DOCTOR SECTION

Ask doctor before use if you have

  • Cough that occurs with too much phlegm(mucus)
  • Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

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. Avoid alcoholic beverages while using this product.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Do not exceed 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 tsp) every 4 hours
Children under 6 years of age
Do not  use

INDICATIONS & USAGE SECTION

Other Information:

  • Each 5 mls contains: sodium 8 mg
  • Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
  • Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Blue Cohosh, Citric Acid, Echinacea Oil, Ginkgo Biloba, Glycerin Seal Root, Honey Flavor, Horehound Herb, Licorice, Golden Seal Root, Menthol, Mullein, Myrrh, Potassium Sobate, Slippery Elm Bark, Sodium Benzoate, Propylene Glycol, Purifed Water, sodium Chloride, Sucralose, Wild Cheery bark, and Zinc Sulfate.

Questions or Comments

OTC - QUESTIONS SECTION

Call Weekdays from 9:30 AM to 5PM EST at Tel 305-261-762

Distributed by

Essential Products Miami FL 33126

www.jjjdistributors.com

Made in U.S.A.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Broncomar Expectorant SFBroncomar Expectorant SF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1540024Broncomar SF Expectorant 100 MG in 5 mL Oral SolutionPSN2
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN2
1540024guaifenesin 20 MG/ML Oral Solution [Broncomar Expectorant]SBD2
310604guaifenesin 20 MG/ML Oral SolutionSCD2
1540024Broncomar SF Expectorant 100 MG per 5 ML Oral SolutionSY2
310604guaifenesin 100 MG per 5 ML Oral SolutionSY2
310604guaifenesin 100 MG per 5 ML Oral SyrupSY2
310604guaifenesin 200 MG per 10 ML Oral SolutionSY2
310604guaifenesin 300 MG per 15 ML Oral SolutionSY2
310604guaifenesin 400 MG per 20 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70242-100-062022-01-28C16284748780-19d75b9d0-1f75-f424-e053-dadaa90a57ceBroncomar Expectorant SF
70242-100-062020-09-24C16284748780-19d75b9d0-1f75-f424-e053-dadaa90a57ceBroncomar Expectorant SF
70242-100-062020-01-31C16284748780-19d75b9d0-1f75-f424-e053-dadaa90a57ceBroncomar Expectorant SF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70242-100-06Broncomar ExpectorantSF177 mL in 1 BOTTLELIQUID1772
70242-100-06Broncomar ExpectorantSF1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70242-100BRONCOMAR EXPECTORANT SF (GUAIFENESIN) LIQUID [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]2Legacy NDC, 2 package rows20200925_fbab201d-32a4-4b0a-ae30-5b2d74b551c3.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70242-10070242-100-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ECHINACEA4N9P6CC1DXIACT
EUCALYPTUS OIL2R04ONI662IACT
GINKGO19FUJ2C58TIACT
GLYCERINPDC6A3C0OXIACT
GOLDENSEALZW3Z11D0JVIACT
HONEYY9H1V576FHIACT
HOREHOUNDK08036XEJVIACT
LICORICE61ZBX54883IACT
MENTHOLL7T10EIP3AIACT
VERBASCUM THAPSUSC9TD27U172IACT
MYRRHJC71GJ1F3LIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ULMUS RUBRA BARK91QY4PXU8QIACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SUCRALOSE96K6UQ3ZD4IACT
PRUNUS SEROTINA BARK5D48E975HAIACT
ZINC SULFATE89DS0H96TBIACT

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
13c0d870-d6eb-4e1e-9c75-ae6a0991f805fbab201d-32a4-4b0a-ae30-5b2d74b551c32016-01-01WarningsExact identifier
spl id: 13c0d870-d6eb-4e1e-9c75-ae6a0991f805
spl set id: fbab201d-32a4-4b0a-ae30-5b2d74b551c3

Reported adverse events (FAERS/openFDA)#

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