Broncotron D

Dosage form: liquid
Ingredients: GUAIFENESIN 200mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 5mL
Labeler: SEYER PHARMATEC, INC.
NDC Code: 11026-2681

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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


Guaifenesin 200 mg........................................................................... Expectorant

Dextromethorphan HBr 20 mg............................................................ Cough Suppressant

Phenylephrine HCL 5 mg.................................................................. Nasal Decongestant

Uses

  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
  • Temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold.
  • Temporarily relieves nasal congestions due to the common cold.

Warnings

Ask the doctor before if you have:

  • heart disease
  • high blood pressure
  • thyroid
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
When using this product:
  • do not exceed recommended dosage.
Stop use and ask a doctor if:

  • your child gets nervous, dizzy, or sleepless.
  • condition lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Do not use

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

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


If pregnant or breastfeeding, ask a health care professional before use.

Directions: SHAKE WELL BEFORE USE

  •      do not take more than 3 doses in any 24 hour period

 Age
 Dose
 adults and children 12 years and over
 take 2 teaspoonfuls every 8 hours
 children 6 years to under 12 years
 1 teaspoonful every 8 hours
 children 2 years to under 6 years
 1/2 teaspoonful every 8 hours
 children under 2 years
 do not use


Other Information:

  • Warning: Phenylketonurics: Contains phenylalanine 15 mg per 5 mL
  • Store at 15-30 degree celsius(59-86 degree farenheit)
  • Alcohol Free and Phenylpropanolamine(PPA) Free

Inactive Ingredients:

Aspartame, cherry flavor, citric acid, glycerin, hydroxyethyl cellulose, kaolin, magnesium aluminium silicate, methylparaben, propylparaben, purified water, sodium citrate, sorbitol.

Any questions or comments, please call toll-free: 1-888-782-3585

BRONCOTRON  D
guaifenesin, dextromethorphan, phenyphrine hydrchloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11026-2681
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
KAOLIN 
MAGNESIUM ALUMINUM SILICATE 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11026-2681-4118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2007
Labeler - SEYER PHARMATEC, INC. (832947126)
Registrant - SEYER PHARMATEC, INC. (832947126)
Establishment
NameAddressID/FEIOperations
Lex Inc.046172888manufacture

Revised: 12/2011
 
SEYER PHARMATEC, INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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