TUSNEL DIABETIC- dextromethorphan, guaifenesin liquid

Tusnel Diabetic by

Drug Labeling and Warnings

Tusnel Diabetic 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 5 mL tsp.)                                      Purpose

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

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

PURPOSE

Purpose

Cough Suppressant

Expectorant

WARNINGS

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.

DO NOT USE

Ask a doctor before use if you have

• a cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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 REACH OF CHILDREN

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

INDICATIONS & USAGE

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 INGREDIENT

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

QUESTIONS

Questions or Comments? 1-866-595-5598

Distributed By: Llorens International Division, Miami FL 33165

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TUSNEL DIABETIC 
dextromethorphan, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-505
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	GRAPE (grape flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-505-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2003
2	NDC: 54859-505-16	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/2003

Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)