BIOCOTRON- dextromethorphan, 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 tsp.)              Purpose

Dextromethorphan Hydrobromide 10 mg.................. Cough Suppressant

Guaifenesin 100 mg .............................................. Expectorant

Purpose

Cough suppressant

Expectorant

Ask a doctor before use if you have

When using this product,do not exceed recommended dosage 

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Do not Use

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.

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

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

Directions Do not take more than 6 doses in any 24-hour period, unless directed by a physician.

 Age Dose
 adults and children 12 years and over 2 teaspoonfuls (10 mL) every 4 hours
 children 6 years to under 12 years 1 teaspoonful (5 mL) every 4 hours 
 children under 6 years  ask a doctor 

Uses

Inactive ingredients citric acid, cherry flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

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

Biocotron Label

BIOCOTRON 
dextromethorphan, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-209
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Water (UNII: 059QF0KO0R)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-209-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2009
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 6064d4a6-914d-4c9b-847a-f6da938540ab
Set id: 91d90a98-38ce-46f0-a31a-ac00937474aa
Version: 6
Effective Time: 20201223
 
Advanced Generic Corporation