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Tusnel

LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients (In each tablet)                      Purpose

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

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

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


Purpose

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


Uses

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

Tusnel

Dextromethorphan HBr, Guaifenesin, Pseudoephedrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54859-801
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 30 mg
Guaifenesin GUAIFENESIN 400 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 60 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
white 20 mm TUSNEL OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54859-801-60 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-07-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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