TUSNEL- dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet 
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 tablet)                      Purpose

Dextromethorphan HBr ................... 30 mg ................... Cough Suppressant

Guaifenesin .................................. 400 mg .................. Expectorant

Pseudoephedrine HCl .................... 60 mg .................... Nasal Decongestant


Uses

Warnings

Ask a doctor before use if you have

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

Do not use

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

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

Directions:Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.


adults and children 12 years of age and over
take 1 tablet every 6 hours
children 6 to under 12 years of age
take 1/2 tablet every 6 hours
children under 6 years of age
ask a doctor


Other Information

Store at controlled room temperature 20-25 degrees C (68-77 degrees F); excursions permitted to 15-30 degrees C (59-86 degrees F)

Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering

Inactive Ingredients: FD and C Blue No. 1, FD and C Blue No. 2, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate type B, titanium dioxide.

Questions or Comments? 1-866-595-5598

TusnelTabLabel

TUSNEL 
dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-801
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize20mm
FlavorImprint Code TUSNEL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-801-6060 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2007
Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Revised: 12/2020
Document Id: 732630f4-d829-4cab-8834-74ce18a6f145
Set id: a8784c65-47a5-4b72-a85b-fb51cfd22c6c
Version: 3
Effective Time: 20201223
 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION