FDA.reportPublic FDA data

Broncomar

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 23:30:10

Label at a glance#

ProductBroncomar DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:(in each 5 ml.)Purpose

Dextromethorphan Hydrobromide 10 mg ....................

Cough Suppressant

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.
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

WARNINGS SECTION

Warnings

Do not exceed recommended dosage

OTC - DO NOT USE SECTION


Do not use

  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) ( certain drugs for depression, psychiatric conditions, or Parkison's disease) or for 2 weeks after stopping MAOI drug.
  • If you do not know if your prescription drug contains MAOI as your doctor or pharmacist before taking this product.
  • If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
  • Avoid alcoholic beverage while taking this product.

Stop use and ask a doctor
  • 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 signserious condition.

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.

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 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 , Eucalyptus Oil , Ginkgo Biloba, Golden Seal Root, Honey Pure, Honey flavor, Horehound Herb, Licorice Root, Menthol, Mullein, Myrrh, Potassium Sorbate, Slippery Elm Bark , Sodium Benzoate, Propylene Glycol, Purified Water, Sodium Chloride, Sucralose, Wild Cherry 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 DM LabelBroncomar DM Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN2
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD2
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY2
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY2
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70242-101-062022-01-28C16284748780-19d75b9d0-77fe-f424-e053-dadaa90a57ceBroncomar DM
70242-101-062020-09-24C16284748780-19d75b9d0-77fe-f424-e053-dadaa90a57ceBroncomar DM
70242-101-062020-01-31C16284748780-19d75b9d0-77fe-f424-e053-dadaa90a57ceBroncomar DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70242-101-06BroncomarDM177 mL in 1 BOTTLELIQUID1772
70242-101-06BroncomarDM1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70242-101BRONCOMAR DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]2Legacy NDC, 2 package rows20200925_6d33888d-cbde-4f67-ade7-60cdbfcb2169.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70242-10170242-101-06

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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ECHINACEA4N9P6CC1DXIACT
EUCALYPTUS OIL2R04ONI662IACT
GINKGO19FUJ2C58TIACT
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
b0882739-0e4e-4942-a99f-916a34ee24ba6d33888d-cbde-4f67-ade7-60cdbfcb21692016-01-01WarningsExact identifier
spl id: b0882739-0e4e-4942-a99f-916a34ee24ba
spl set id: 6d33888d-cbde-4f67-ade7-60cdbfcb2169

Reported adverse events (FAERS/openFDA)#

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