BIOGTUSS NF- dextromethorphan, guaifenesin, phenylephrine 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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Active Ingredients: (in each 5 mL tsp.)              Purpose

Dextromethorphan HBr 28 mg.................. Cough Suppressant

Guaifenesin 388 mg .............................................. Expectorant

Phenylephrine HCl 10 mg...........................Nasal Decongestant

Purpose

Cough suppressant

Expectorant

Nasal Decongestant

Uses

Warnings

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.

Ask a doctor before use if you have

Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if

Keep out of reach of children. In case of accidental overdose, seek advice or a doctor or contact a Poison Control Center right away.

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

Directions Do not exceed 6 doses in 24 hours.

 adults and children over 12 years of agetake 1 teaspoonful (5 mL) every 6-8 hours 
children 6 to under 12 years of age take 1/2 teaspoonful (2.5 mL) every 6-8 hours
children under 6 years of age consult a doctor before use

Inactive Ingredients  citric acid, FDandC yellow No 6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

Questions or comments? 1-305-403-3788

Monday - Friday 9:00AM - 5:00 PM EST.

Manufactured For: Advanced Generic Corporation, Miami, Fl 33147

www.advancedgeneric.com

BioGtussNFLabel

BIOGTUSS  NF
dextromethorphan, guaifenesin, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-242
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide28 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin388 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-242-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2010
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 20a2b312-cedb-44e7-ae7b-c945c5000ab3
Set id: 17414989-bc15-405d-b893-028250d5becf
Version: 4
Effective Time: 20201223
 
Advanced Generic Corporation