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 HBr 10 mg.................. Cough Suppressant

Guaifenesin 187 mg .............................................. Expectorant

Purpose

cough suppressant

expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold

helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

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

Directions Do not take more than 8 teaspoonfuls in any 24-hour period

 adults and children 12 years of age and over take 2 teaspoonfuls (10 mL) every 4 hours
 children 6 years to under 12 years of agetake 1 teaspoonful every 4 hours 
 children 2 years to under 6 years of age take 1/2 teaspoonful every 4 hours
 children under 2 years of ageconsult 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 citric acid, glycerin, methylparaben, natural and artificial flavors, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions or comments? 1-305-403-3788

BiospecDMX264

BIOSPEC  DMX
dextromethorphan, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-264
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) Guaifenesin187 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-264-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2015
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 2a2354c5-aee5-4dc9-b397-3d10c72a9b58
Set id: eb29e7cc-e6bb-4b33-88ee-aa3acd6f2970
Version: 2
Effective Time: 20201223
 
Advanced Generic Corporation