TUSNEL DM PEDIATRIC- dextromethorphan, guiafenesin, pseudoephedrine hcl solution/ drops

Tusnel DM by

Drug Labeling and Warnings

Tusnel DM 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 1 mL (dropperful)                    Purpose

Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant

Guaifenesin........................25mg................................................Expectorant

Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant

PURPOSE

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 who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, ask a doctor or pharmacist before giving 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.

INDICATIONS & USAGE

Other information

• store at controlled room temperature 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature]
  
• Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering
• Oral dosing device enclosed
  

INACTIVE INGREDIENT

Inactive ingredients citric acid, D and C Red Number 33,FD and C Blue #1, flavor, glycerin, propylene glycol, sodium benzoate, sodium saccharin, water.

QUESTIONS

Questions or Comments? 1-866-595-5598

DOSAGE & ADMINISTRATION

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

Age	Weight	Dose
Children 2 to under; 6 years of age	24 -47 lbs	Take 2 mL (two dropperfuls); every 4 to 6 hours
Children under 2 years of age	Under 24 lbs	ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TUSNEL DM  PEDIATRIC
dextromethorphan, guiafenesin, pseudoephedrine hcl solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-603
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	25 mg  in 1 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	7.5 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-603-02	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/01/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/1993

Labeler - Llorens Pharmaceutical International Division (037342305)