BIONEL PEDIATRIC- dextromethorphan, guaifenesin, pseudoephedrine 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

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

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

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

Uses

Warnings
Do not use in 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 have
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 ingredients aspartame, 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 finalpart34110/01/2009
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 27ff6a28-8f3a-4a42-9cc9-0fe1afb85799
Set id: 271c5895-25f5-4162-a278-6629b0ad03c1
Version: 7
Effective Time: 20201223
 
Advanced Generic Corporation