BIO DTUSS DMX - brompheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine hydrochloride 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


Brompheniramine Maleate...................... 1mg ..................................Antihistamine
Dextromethorphen HBr........................... 20 mg ............................Cough Suppressant
Pseudoephedrine HCl............................. 30mg .............................Nasal Decongestant

Uses:


Warnings:

Do Not Use:


Ask a doctor before use if you have:

Stop use and ask a doctor if:


Keep out of 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:

 adults and children 12 years of age and over
 take 1 teaspoonfull every 6 hours
 children 6 to under 12 years of age
 take 1/2 teaspoonfull every 6 hours
 children under 6 years of age
 ask doctor

Other Information:

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

 Inactive Ingredients:

 Glycerin, Propylene Glycol, Methylparaben, Propylparaben, Sucrose, Citric Acid, Sodium Citrate, D and C Red #33, FD and C Blue #1, Grape Flavor and Purified Water.

Question and Comments? 1-305-403-3788

Advanced Generic Corporation, Miami, FL 33166

www.advancedgeneric.com

biodtusslabel


BIO DTUSS  DMX
brompheniramine maleate, dextromethorphan, pseudoephedrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-203
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
SUCROSE 
CITRIC ACID MONOHYDRATE 
SODIUM CITRATE 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:45737-203-16473 mL in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2011

Labeler - Advanced Generic Corporation (831762971)
Registrant - Advanced Generic Corporation (831762971)
Establishment
NameAddressID/FEIOperations
Lex Inc.046172888manufacture

Revised: 01/2012 Advanced Generic Corporation