Tusnel DM Pediatric

Dosage form: solution/ drops
Ingredients: Guaifenesin 25mg in 1mL, PSEUDOEPHEDRINE HYDROCHLORIDE 7.5mg in 1mL, DEXTROMETHORPHAN HYDROBROMIDE 2.5mg in 1mL
Labeler: Llorens Pharmaceutical International Division
NDC Code: 54859-603

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients in each 1 mL (dropperful)                    Purpose

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

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

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



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

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.


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


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

Questions or Comments? 1-866-595-5598


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

TUSNEL DM  PEDIATRIC
dextromethorphan, guiafenesin, pseudoephedrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-603
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin25 mg  in 1 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE7.5 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
SODIUM BENZOATE 
SACCHARIN SODIUM 
PROPYLENE GLYCOL 
WATER 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:54859-603-0260 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/1993
Labeler - Llorens Pharmaceutical International Division (037342305)

Revised: 04/2013
 
Llorens Pharmaceutical International Division

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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