BIOCOF- dextromethorphan hydrobromide, guaifenesin, phenylephrine hcl 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 tps.)        Purpose

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

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

Phenylephrine HCL.....10 mg...............................................Nasal Decogestant


Uses:

Warnings:

Ask a doctor before use if you have:

Ask a  doctor before use if you have

Ask a doctor or pharmacist before useif you are taking any other nasal decongestant or stimulant.

When using this product do not use more than directed.

Stop use and ask a doctor if: you get nervous, dizzy, or sleepless; symptoms do not get better within 7 days, or are accompanied by fever


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.

Directions 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

Uses

Inactive Ingredients: Cherry flavor, Citric Acid, Glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucralose


Questions or comments? 1-305-403-3788

Manufactured for: Advanced Generic Corporation
                          Miami, FL 33166

biocof label

BIOCOF 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-249
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-249-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2012
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: e0c8cde4-ca2e-4859-8bc3-37e21d932b9e
Set id: 6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6
Version: 3
Effective Time: 20201223
 
Advanced Generic Corporation