BIONEL PEDIATRIC- dextromethorphan, guaifenesin, pseudoephedrine hydrochloride liquid 
Advanced Generic Corporation

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AGC-BionelPed 207

Active Ingredients: (in each 5 mL tsp.)              Purpose

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

Dextromethorphan Hydrobromide 5 mg.................. Cough Suppressant

Pseudoephedrine HCl 15 mg.................................. Nasal Decongestant

Uses


Warnings
Do not usein a child who is 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 you are
taking a prescription drug that contains a MAOI; ask a doctor or
pharmacist before taking this product.

Ask a doctor before use if your child hav

e


Stop use and ask a doctor if


Keep out of reach of children.

If pregnant or breast-feeding,ask a health professional before use.

Directions Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

Children 6 to under 12 years of age; 45 lbs to under 95 lbs; Take 2 teaspoonfuls (10mL) every 4 to 6 hours

Children 2 to under 6 years of age; 25 lbs to under 45 lbs; Take 1 teaspoonful (5mL) every 4 to 6 hours

Children under 2 years of age; Under 25 lbs; Ask a doctor

Other information


Warning: Phenylketonuric: Contains 14 mg of Phenylalanine per 5 mL (one teaspoonful) dose.

Inactive ingredientsaspartame, citric acid, corn syrup, D and C Red No 33, methylparaben, natural and artificial flavors, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water.

Questions or comments?1-305-403-3788

Manufactured For:Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

BionelPedLabel

BIONEL  PEDIATRIC
dextromethorphan, guaifenesin, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-207
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ASPARTAME (UNII: Z0H242BBR1)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-207-16473 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 DrugM01210/01/2009
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2024
Document Id: 29bc44a9-43f2-1d34-e063-6394a90aec4a
Set id: 271c5895-25f5-4162-a278-6629b0ad03c1
Version: 8
Effective Time: 20241220
 
Advanced Generic Corporation