TUSNEL DM PEDIATRIC- dextromethorphan, 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

Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant

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

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



Uses


Warnings

Do not use in child who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, 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.


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.

Questions or Comments? 1-866-595-5598


Directions Do not exceed more than 4 doses in any 24-hour periodor 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

tusnelDMPed

TUSNEL DM  PEDIATRIC
dextromethorphan, guiafenesin, pseudoephedrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-603
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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE2.5 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 (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:54859-603-0260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/1993
Labeler - Llorens Pharmaceutical International Division (037342305)

Revised: 12/2020
Document Id: a3f45673-555c-46e7-9afe-7e6276f1b327
Set id: d915eab8-013e-4ce3-b358-0d531e5ca1ba
Version: 7
Effective Time: 20201223
 
Llorens Pharmaceutical International Division