TUSNEL DIABETIC- dextromethorphan, guaifenesin liquid 
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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DRUG FACTS

 Active Ingredients ( in each 5 mL tsp.)                                      Purpose

 Dextromethorphan HBr USP........ 10 mg ................................. Cough Suppressant

 Guaifenesin USP ............. 100 mg ......................................... Expectorant

Purpose

Cough Suppressant

Expectorant

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 if 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 giving this product.

Ask a doctor before use if you have


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

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Center right away.

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

Directions

 Do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.

 Age Dose
 Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
 Under 2 years of age Do not use

Uses
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Inactive Ingredients: anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate and sucralose.

Questions or Comments? 1-866-595-5598

Distributed By: Llorens International Division, Miami FL 33165

TusnelDiabeticLabel

TUSNEL DIABETIC 
dextromethorphan, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-505
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
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-505-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2003
2NDC:54859-505-16472 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2003
Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Revised: 7/2022
Document Id: 7bb71b9d-9085-4df4-addb-2f61e1dd658a
Set id: 66b3c094-809e-4d2c-bc15-46563de685cb
Version: 4
Effective Time: 20220710
 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION