BIOSPEC DMX- 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 15 mg.................. Cough Suppressant

Guaifenesin 25 mg .............................................. Expectorant

Uses

Warnings
Ask a doctor before use if you have

Stop use and ask a doctor if

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

Keep out of reach of children.

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

adults and children 12 years and over, 1 teaspoonfuls (5 ml) every 4 hours

children 6 years to under 12 years, 1/2 teaspoonful (2.5 ml) every 4 hours

children 4 to 6 years, 1/4 teaspoonful (1.25 ml) every 4 hours

children under 4 years of age, consult a doctor

Other information store at room temperature 15-30 C (59-86 F).

Tamper Evident Feature Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

Inactive ingredients Cherry Flavor, Glycerin, Menthol, Potassium Guaiacol Sulfonate,
Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Water.

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

BiospecDMXLabelBiospecDMXLabel

BIOSPEC  DMX
dextromethorphan, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Menthol (UNII: L7T10EIP3A)  
Water (UNII: 059QF0KO0R)  
POTASSIUM GUAIACOLSULFONATE (UNII: TTK33Z47F1)  
Glycerin (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-211-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2009
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 5c91244c-f997-481e-b9f2-b2814efc6e7d
Set id: 54fcf605-39e9-47dd-ada4-1c4749af8dd8
Version: 5
Effective Time: 20201223
 
Advanced Generic Corporation