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Manufacturer:Advanced Generic Corporation
Category:Over-the-counter (OTC) Marketed Drugs

Drug Facts

BIOBRON DX - dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride liquid 
Advanced Generic Corporation

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


  • 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.


  • 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.

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


dextromethorphan, guaifenesin, phenylephrine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-246
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 20 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 200 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (Cherry Flavor) Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:45737-246-16 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/01/2009

Labeler - Advanced Generic Corporation (831762971)

Revised: 04/2011 Advanced Generic Corporation

Reproduced with permission of U.S. National Library of Medicine

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