TUSNEL PEDIATRIC - guiafenesin, pseudoephedrine hcl solution/ drops 
Llorens Pharmaceutical International Division

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 1 mL (dropperful)                    Purpose

Guaifenesin........................25mg................................................Expectorant

Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant



Uses


Warnings

Do not use in 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 your child's prescription drug contains an
MAOI, ask a doctor or pharmacist before giving this product.


Ask a doctor before use if your child has

When using this product
Stop use and ask a doctor if


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


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

Age
WeightDose
Children 2 to under
6 years of age
24 -47 lbs
 Take 2 mL (two dropperfuls)
 every 4 to 6 hours
Children under 2 years of age
Under 24 lbs
 ask a doctor


Other information


Inactive ingredients
citric acid, D and C Red Number 33,FD and C Blue #1, flavor, glycerin, propylene glycol, sodium benzoate, sodium saccharin, water.

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tusnelpediatricdropslabel
TUSNEL PEDIATRIC 
guiafenesin, pseudoephedrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-602
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin25 mg  in 1 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-602-0260 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2006
Labeler - Llorens Pharmaceutical International Division (037342305)

Revised: 1/2013
Document Id: 4d96e27d-d9fc-460f-bfbb-6dd7b9185251
Set id: f9fe6883-6e10-4851-8acb-a6df6e862375
Version: 4
Effective Time: 20130130
 
Llorens Pharmaceutical International Division