TUSNEL PEDIATRIC- dextromethorphan, guiafenesin, pseudoephedrine hcl liquid

Tusnel by

Drug Labeling and Warnings

Tusnel by is a Otc medication manufactured, distributed, or labeled by Llorens Pharmaceutical International Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients(in each 5 ml tsp.)                                  Purpose

Dextromethorphan HBr........5mg..................................................Cough Suppressant

Guaifenesin........................50mg................................................Expectorant

Pseudoephedrine HCl..........15mg..................................................Nasal Decongestant

PURPOSE

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

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 for 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 taking this product.

DO NOT USE

Ask a doctor before use if your child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• a cough that occurs with too much phlegm (mucus)
• a persistent or chronic cough such as occurs with asthma

When using this product

• do not exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occurs
• symptoms do not get better within 7 days or accompanied by fever
• cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.

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.

DOSAGE & ADMINISTRATION

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

Age	Weight	Dose
Children 6 to under; 12 years of age	45 lbs to under; 95 lbs	Take 2 teaspoonfuls (10 mL); every 4 to 6 hours
Children 2 to under; 6 years of age	25 lbs to under; 45 lbs	Take 1 teaspoonful (5mL); every 4 to 6 hours
Children under 2 years of age	Under 25 lbs	ask a doctor

INDICATIONS & USAGE

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves these symptoms occurring with a cold: nasal congestions, cough due to minor throat and bronchial irritation.

INACTIVE INGREDIENT

Inactive ingredients astificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralos

QUESTIONS

Questions or Comments? 1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TUSNEL  PEDIATRIC
dextromethorphan, guiafenesin, pseudoephedrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-544
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	50 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-544-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2006
2	NDC: 54859-544-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2006

Labeler - Llorens Pharmaceutical International Division (037342305)