BIONATUSS DXP- dexbrompheniramine maleate, dextromethorphan, 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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Drug Facts

Active Ingredients (in each 5 mL tsp.)                                           Purpose

Dexbrompheniramine Maleate.............2mg................................Antihistamine

Dextromethorphan HBr..................20mg.................................Cough Suppressant

Phenylephrine HCL......................10mg................................. Nasal Descongestant

Purpose

Antihistamine

Cough Suppressant

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 your prescription contains an MAOI, ask a doctor or pharmacist before using the product.

Ask a doctor before use if you have

Ask a docotor before use if you are taking sedatives or tranquilizers

When using this product

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: Do not exceed more than 6 doses in any 24-hour period or
as directed by a doctor.

  Adults and children
 12 years of age and over
  take 1 teaspoonful (5 mL)
 every 4 hours
  Children 6 to under
 12 years of age
  take 1/2 teaspoonful (2.5 mL)
 every 4 hours
  Children under 6 years of age
  ask a doctor

Inactive ingredients: artificial flavor, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, water, sodium citrate and sucralose.

Questions or comments? 1-305-403-3788

bionatusslabel

BIONATUSS  DXP
dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-210
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
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
FlavorRASPBERRY (Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-210-16473 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: 2c36395e-c0a5-42a6-ba75-977b33b65aac
Set id: e57de19a-bf2f-405c-bc84-6ccae6055a46
Version: 3
Effective Time: 20201223
 
Advanced Generic Corporation