TUSNEL DM- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
Llorens Pharmaceutical International Division, Inc.

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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In each 5 mL

Dextromethorphan HBr - 20 mg

Guaifenesin - 400 mg

Phenylephrine HCl - 10 mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

Warnings

Do not use if you are taking a 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 using this product.

Ask a doctor before use if you have

Stop use and ask a doctor if you get

If pregnant or breast-feeding, ask a doctor before using this product

Keep out of reach of children. In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

Directions: Do not exceed 6 doses in 24 hour

 Age Dose
 Adults and children over 12 years of age Take 5 mL (one teaspoonful) every 4 hours
 Children under 12 years of age Ask a doctor

Inactive ingredients:artificial and natural flavor, citric acid, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Questions or Comments? 1-866-595-5598

TusnelDM

TUSNEL  DM
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-517
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-517-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2019
Labeler - Llorens Pharmaceutical International Division, Inc. (037342305)
Registrant - Llorens Pharmaceutical International Division, Inc. (037342305)
Establishment
NameAddressID/FEIBusiness Operations
Llorens Pharmaceutical International Division, Inc.037342305manufacture(54859-517)

Revised: 6/2019
Document Id: 96a211dd-6812-48f8-8fef-ddfa47995cfd
Set id: fe457e6d-422d-496c-bcb9-33594f3c42ff
Version: 1
Effective Time: 20190609
 
Llorens Pharmaceutical International Division, Inc.