TUSNEL- dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet

Tusnel by

Drug Labeling and Warnings

Tusnel by is a Otc medication manufactured, distributed, or labeled by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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 INGREDIENT

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

Questions or Comments? 1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TUSNEL 
dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-801
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	TUSNEL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-801-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2007

Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)