TUSNEL-DM PEDIATRIC- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops 
LLORENS PHARMACEUTICALS 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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Active Ingredients in each (1 mL)

Dextromethorphan HBr 2.5 mg

Guaifenesin 25 mg

Phenylephrine HCl 1.25 mg

Purpose

Cough suppressant

Expectorant

Nasal Decongestant

Uses

Warnings

Do not use in child whos 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 your doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

When using this product

Stope use and ask doctor if

Keep out of reach of children. In case 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 Weight Dose
 Children 2 to under 6 years of age 24-47 lbs Take 2 mL every 4-6 hours
 Children under 2 years of age Under 24 lbs Ask a doctor

Inactive ingredients: Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions or Comments? 1-866-595-5598

image description

TUSNEL-DM PEDIATRIC 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-606
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE2.5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN25 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE1.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
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:54859-606-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2019
Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Revised: 12/2019
Document Id: e0fc03c4-634f-4ba2-a194-9a350d7b2937
Set id: 64e36b02-b5be-4d20-8818-cb5b23596671
Version: 1
Effective Time: 20191229
 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION