TUSNEL PEDIATRIC- dextromethorphan, guiafenesin, pseudoephedrine hcl liquid 
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 5 ml tsp.)                                  Purpose

Dextromethorphan HBr........5mg..................................................Cough Suppressant

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

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



Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings
Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking 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.

AgeWeightDose
Children 6 to under
12 years of age
45 lbs to under
95 lbs
 Take 2 teaspoonfuls (10 mL)
 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 ageUnder 25 lbs ask a doctor

Uses


Inactive ingredients
astificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralos

Questions or Comments? 1-866-595-5598

tusnelpediatriclabel

TUSNEL  PEDIATRIC
dextromethorphan, guiafenesin, pseudoephedrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-544
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-544-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
2NDC:54859-544-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2006
Labeler - Llorens Pharmaceutical International Division (037342305)

Revised: 12/2020
Document Id: c018e718-f343-42eb-a069-a51a55c5b0cb
Set id: 82f447f6-4f1b-4f56-9d7d-ea02adeea88c
Version: 4
Effective Time: 20201223
 
Llorens Pharmaceutical International Division