TUSNEL SF- dextromethorphan hbr, guaifenesin 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 - 10 mg

Guaifenesin - 100 mg

Cough Suppressant

Expectorant

Uses

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 us if you have

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

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 6 doses in any 24-hour period.

 Age Dose
 Adults and children 12 years and over 2 teaspoonfuls (10 mL) every 4 hours
 Children under 12 years Ask a doctor

Inactive ingredients anhydrous citric acid, avor, methylparaben, propylene glycol, propylparaben, puri ed water, sodium citrate dihydrate, and sucralose.

Questions or comments? 1-866-595-5598

TusnelSF

TUSNEL  SF
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-506
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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:54859-506-04118 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)

Revised: 6/2019
Document Id: a6d82b30-2a69-4ab0-ac2a-9f1014fe3df2
Set id: cb43b4df-5ccc-416e-abcd-98f079b3f2bb
Version: 1
Effective Time: 20190609
 
Llorens Pharmaceutical International Division, Inc.