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Tusnel by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

Dosage form: tablet
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 30mg, GUAIFENESIN 400mg, PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
NDC Code: 54859-801

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.

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

  • temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
  • temporary relief of cough due to minor throat and bronchial irritation
  • helps to control reflex that causes coughing

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition.

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or accompanied by fever
  • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache

Do not use
  • if you are now taking a prescription monamine 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 you are taking a prescription drug that contains on MAOI, ask your doctor or pharmacist before taking this product.

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

TUSNEL 
dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-801
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
FD&C BLUE NO. 1 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
WATER 
SODIUM STARCH GLYCOLATE TYPE B POTATO 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize20mm
FlavorImprint CodeTUSNEL
Contains    
Packaging
#Item CodePackage Description
1NDC:54859-801-6060 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2007
Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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