BIO-G-TUSS PEDIATRIC DROPS- 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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Active ingredients

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

Warnings

Do not exceed recommended dosage

Do not use this product

Stop use and ask a doctor

Keep out of reach of children

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

Directions

 AgeDose 
 children 6 to under 12 years of age2 mL every 6-8 hours 
 chidren 2 to under 6 years of age1 mL every 6-8 hours 
 children under 2 years of ageconsult a doctor 

Inactive ingredients

citric acid, grape flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions or Comments

1-305-403-3788

BioGTussPedDrops

BIO-G-TUSS  PEDIATRIC DROPS
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-240
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN88 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-240-0260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2016
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 7d649187-a213-4d0d-be73-571cca8a19d5
Set id: 42045759-eaf2-4ffb-8a68-043f661acf8a
Version: 3
Effective Time: 20201223
 
Advanced Generic Corporation