Biobron DX

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 20mg in 5mL, Guaifenesin 200mg in 5mL, Phenylephrine Hydrochloride 10mg in 5mL
Labeler: Advanced Generic Corporation
NDC Code: 45737-246

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 tsp.)              Purpose

Dextromethorphan Hydrobromide 20 mg.................. Cough Suppressant

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

Phenylephrine HCl 10 mg.................................. Nasal Decongestant


Uses

  • Temporarily relieves these symptoms, due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies
  • Cough due to minor throat and bronchial irritation
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
  • Nasal congestion
  • Reduces swelling of nasal passages.

Warnings

  • Do not exceed recommended dosage
  • A persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reoccur or is accompanied by a fever, rash or persistent headache, consult a doctor
  • If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
  • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

Do not Use

  • For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phelgm (mucus), unless directed by a doctor  
  • If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.
If you are now taking a prescription monoamine oxidase inhibitor (MAOI)
(certain drugs for depression, psychiatric or emotional conditions or
Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you
do not know if you are taking a prescription drug that contains an MAOI;
ask your doctor or pharmacist before taking this product.

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

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


Directions Do not exceed 6 doses in 24 hours.

 adults and children
 12 years of age and over
 take 1 teaspoonful (5 mL)
 every 4 hours
children 6 to under
 12 years of age
 take 1/2 teaspoonful (2.5 mL)
 every 4 hours
 children under 6 years of age

 ask a doctor



Other information  store at room temperature 15 - 30 degrees celcius (59 - 86 degrees farhenheits).

Tamper Evident Feature:
Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com

Inactive ingredients glycerin, propylene glycol, methylparaben, propylparaben, citric acid, sodium citrate, saccharin calcium,
cherry flavor, purified water.

BIOBRON  DX
dextromethorphan, guaifenesin, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-246
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide20 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin200 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
CITRIC ACID MONOHYDRATE 
SODIUM CITRATE 
SACCHARIN CALCIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45737-246-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2009
Labeler - Advanced Generic Corporation (831762971)

Revised: 04/2011
 
Advanced Generic Corporation

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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