BIO T PRES-B - brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine 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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Drug Facts

Active Ingredients (in each 5 mL tsp)             Purpose

Brompheniramine maleate 1 mg                                Antihistamine

Dextromethorphan HBr 5 mg                                  Cough Suppressant 

Phenylephrine HCl 2.5 mg                                      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 drug contains an MAOI, ask a doctor or pharmacist before taking this product. Do not use on a child under 2 years of age.


Ask a doctor before use if you have

Ask a doctor or a pharmacist before

Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.

When using this product

Stop use and ask a doctor if

Keep out of reach of children.In case of accidental 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.

adults and children 12 years of age and over
take 1 teaspoonfuls (5 mL) every 4 hours
children 6 to under 12 years of age
take 1/2 teaspoonfuls (2.5mL) every 4 hours
children 2 years to under 6 years of age
ask a doctor
children under 2 years of age
do not use

Other Information

Inactive Ingredients

Water, citric acid, methylparaben, glycerin, propylene glycol, propylparaben, sodium citrate, flavor, sucralose

Questions or comments: 1-305-403-3788

Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

tpreslabel

BIO T PRES-B 
brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-226
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE4 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
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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:45737-226-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2012
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2012
Document Id: f84c77b1-d231-425c-9bc7-b88424c9129c
Set id: 4467666b-04cb-4cce-a300-871fc39d6df7
Version: 1
Effective Time: 20121218
 
Advanced Generic Corporation