BIO-S-PRES DX- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops 
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 1mL)                   Purpose

Dextromethorphan HBr, 5 mg ................................. Cough Suppressant

Guaifenesin, 50 mg ................................................ Expectorant

Phenylephrine HCl, 2.5 mg ...................................... Nasal Decongestant



Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings:


Do not exceed recommended dosage.

Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions:Do not exceed more than 6 doses in any 24-hour period. Measure with the dosage device provided. Do not use with any other device.

Age
Dose
Children 2 to under 6 years of age
1 mL every 4 hours
Children under 2 years of age
Consult a doctor

Inactive ingredients:Artificial  and natural Cherry Flavor, Citric Acid, FD and C Red No. 40, Glycerin, Methyl Paraben (as preservative), Propylene Glycol, Propylparaben (as preservative), Purified Water, sodium citrate, and sucralose

Questions or comments? 1-305-403-3788

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold.

biospres

BIO-S-PRES  DX
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-230
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-230-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2013
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: b4c750b5-60bd-4135-a52f-529f315f3847
Set id: b3b9c298-4524-4ba7-a831-3bf3c2950e27
Version: 4
Effective Time: 20201223
 
Advanced Generic Corporation