Your browser does not support JavaScript! BIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

BIO-Z-COUGH (dextromethorphan hydrobromide, guaifenesin) liquid
[Advanced Generic Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active Ingredients (in each 5 mL tps.)                               Purpose

Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant

Guaifenesin.... 400 mg........................................................Expectorant



Uses:

  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

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, chronic bronchitis, or emphysema.


When using this product do not use more than directed.

Stop use and ask a doctor before use if:

  • cough lasts 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 oxidase inhibitor (MAOI) (certain drugs of 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 MAOI; ask your 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 right away.

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

Direction: do not exceed more than 6 doses in any 24 hours period.

Adults and children 12 years of age and over.
 Take 1 teaspoonful (5 mL) every 4 hours
Children under 12 years of age.
 Consult a physician


Other Information:
  • Store at room temperature 15 - 30 degrees celsius (59 - 86 degrees farenheit)
  • Tamper evident feature Do not use if seal under cap is torn, broken or missing.
  • Avoid excessive heat or humidity.



Inactive Ingredients:

Citric Acid, eucalyptus oil, menthol, methylparaben, propylparaben, propylene glycol, sodium citrate, polyethylene glycol, grape flavor, sucralose, and purified water.


 
Questions or comments? 1-305-403-3788

Manufactured for: Advanced Generic Corporation
                          Miami, FL 33166

www.advancedgeneric.com

biozcof label

BIO-Z-COUGH 
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45737-251
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN ) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
EUCALYPTUS OIL 
MENTHOL 
METHYLPARABEN 
PROPYLPARABEN 
POLYETHYLENE GLYCOLS 
SUCRALOSE 
WATER 
PROPYLENE GLYCOL 
SODIUM CITRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-251-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2012
Labeler - Advanced Generic Corporation (831762971)

Revised: 10/2012
 
Advanced Generic Corporation

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services