BIOPHEX TR- guaifenesin, phenylephrine hcl tablet 
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 tablet)           Purpose

Guaifenesin .............. 388 mg .................  Expectorant

Phenylephrine HCl ....  10 mg .................   Nasal Decongestant

Purpose

Expectorant

Nasal Decongestant

Uses

Temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies

Warnings

Do not exceed recommended dosage

Do not use this product if you are taking a 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Directions: Do not exceed recommended doses in a 24-hour period

Adults and children 12 years of age and over              1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours

Children 6 to 12 years of age                                       1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours

Children under 6 years of age                                      Ask a doctor

Inactive ingredients: Colloidal silicon dioxide, crocarmellose sodium, hydroxy propyl methyl cellulose (HPMC), microcrystalline cellulose, polyethylene glycol 400 (PEG-400), povidone, pregelatinized starch, stearic acid, talc

Questions or comments? 305-403-3788

biophex label

BIOPHEX  TR
guaifenesin, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-606
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code BP;AGC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-606-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2014
Labeler - Advanced Generic Corporation (831762971)

Revised: 5/2014
Document Id: 935db096-3fe5-44ca-b041-210d4ecfb96a
Set id: 81a4cf27-585b-484b-b0d8-4e21b4016418
Version: 1
Effective Time: 20140530
 
Advanced Generic Corporation