Broncotron

Manufacturer
Seyer Pharmatec, Inc.
Effective date
2011-12-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:49:55

Label at a glance#

ProductBroncotron
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients(in each 5 mL teaspoonful) .......................................... Purpose

Dextromethorphan HBR, 10 mg..................................................................Cough suppressant

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

OTC - PURPOSE SECTION

Uses:

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with a cold.
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

WARNINGS SECTION

Warnings:

Ask a 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, bronchitis, or emphysema.
Stop use and ask a doctor if:

  • Cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

OTC - DO NOT USE SECTION

Do not use if you are now taking a prescription monoamine oxidase (MOAI) (certain drugs for depression, pychiatric, or emotional conditions, or Parkison's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than 6 doses in any 24-hour period, unless directed by a physician.

AgeDoses
 adults and children 12 years and over
 2 teaspoonfuls every 4 hours
 children 6 years to under 12 years
 1 teaspoonful every 4 hours
 children under 6 years
 ask a doctor

INDICATIONS & USAGE SECTION

Other information:

  • Phenylketonuric: contains Phenylalanine 35mg/5mL
  • store at room temperature.

INACTIVE INGREDIENT SECTION

Inactive ingrdients:

Aspartame, citric acid, flavor, glycerine, hydroxyethyl cellulose, methylparaben, propyparaben, sodioum citrate, water.

OTC - QUESTIONS SECTION

Questions or Comments call: 1(800) 782- 3585.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

broncotronlabelbroncotronlabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11026-2640-42021-10-18C16284748780-197449f38-cfd1-f6ea-e053-dbdaa90aa703Drug Facts
11026-2640-42019-11-13C16284748780-197449f38-cfd1-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11026-2640-4ML - Milliliter11026-26400d64709b-bdde-4dbb-80e8-c120201e07d212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GUAIFENESINACTIVE MOIETY495W7451VQ1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11026-264011026-2640-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
af824ff7-946b-44fb-bd41-edc94b3b946b6cbf83f6-cbf4-4e5b-a383-6d71124547bc2023-05-26WarningsExact identifier
spl set id: 6cbf83f6-cbf4-4e5b-a383-6d71124547bc

Reported adverse events (FAERS/openFDA)#

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