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Tusnel Pediatric by Llorens Pharmaceutical International Division

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, Guaifenesin 50mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 15mg in 5mL
Labeler: Llorens Pharmaceutical International Division
NDC Code: 54859-544

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 5 ml tsp.)                                  Purpose

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

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

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



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


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.


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.


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

Age
WeightDose
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


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
WARNING: Phenylketonuric: Contains 12.5 mg of Phenylalanine
per 5 mL ( one teaspoonful) dose


Inactive ingredients
aspartame, citric acid, corn syrup, D and C Red Number 33, methylparaben,
natural and artificial flavors, potassium citrate, potassium sorbate,
propylene glycol, propylparaben, purified water.

Questions or Comments? 1-866-595-5598

TUSNEL  PEDIATRIC
dextromethorphan, guiafenesin, pseudoephedrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-544
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin50 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CITRIC ACID MONOHYDRATE 
CORN SYRUP 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:54859-544-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2006
Labeler - Llorens Pharmaceutical International Division (037342305)

Revised: 01/2013
 
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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