BIO-Z-COUGH - dextromethorphan hydrobromide and guaifenesin 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.

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DRUG FACTS

Active Ingredients (in each 5 mL tps.)                               Purpose

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

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



Uses:

Warnings:

Ask a doctor before use if you have:


When using this product do not use more than directed.

Stop use and ask a doctor before use if:





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:



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
Document Id: 58efaddb-718a-4ddf-b8aa-76ce8e5eb009
Set id: 05e70eab-1467-4b09-991e-ef03f222e021
Version: 1
Effective Time: 20121003
 
Advanced Generic Corporation