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Tusnel Pediatric by Llorens Pharmaceutical International Division

Dosage form: solution/ drops
Ingredients: Guaifenesin 25mg in 1mL, PSEUDOEPHEDRINE HYDROCHLORIDE 7.5mg in 1mL
Labeler: Llorens Pharmaceutical International Division
NDC Code: 54859-602

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

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

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



Uses
  • temporarily relieves these symptoms due to the common cold and thin bronchial secretions to make coughs more productive


Warnings

Do not use in child who 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 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.


Directions Do not exceed more than 4 doses in any 24-hour period
or 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


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

TUSNEL PEDIATRIC 
guiafenesin, pseudoephedrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-602
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
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
SODIUM BENZOATE 
SACCHARIN SODIUM DIHYDRATE 
PROPYLENE GLYCOL 
WATER 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:54859-602-0260 mL in 1 BOTTLE, DROPPER
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

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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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