TUSNEL-DM PEDIATRIC- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

Tusnel-DM Pediatric by

Drug Labeling and Warnings

Tusnel-DM Pediatric 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 (1 mL)

Dextromethorphan HBr 2.5 mg

Guaifenesin 25 mg

Phenylephrine HCl 1.25 mg

PURPOSE

Purpose

Cough suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

Uses

• Temporary relief of cough due to minor throat and bronchial irritation
• Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
• Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.

WARNINGS

Warnings

Do not use in child whos is 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 child's prescription drug contains an MAOI: ask your doctor or pharmacist before giving this product.

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
• a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

When using this product

• do not exceed the recommended dosage.

Stope use and ask doctor if

• nervousness, dizziness or sleeplessness occurs
• 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. A persistent cough may be a sign of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case 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 2 to under 6 years of age	24-47 lbs	Take 2 mL every 4-6 hours
Children under 2 years of age	Under 24 lbs	Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients: Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

QUESTIONS

Questions or Comments? 1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TUSNEL-DM PEDIATRIC 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-606
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	2.5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	25 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	1.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
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: 54859-606-01	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2019

Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)