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Defensol-ito

Dosage form: solution
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 4mg in 1mL, GUAIFENESIN 50mg in 1mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1mL
Labeler: Menper Distributors, Inc
NDC Code: 53145-333

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.

Active Ingredient (in each 1 mL, dropperful)                                      Purpose

Dextromethorphan 4 mg............................................................................Cough Suppressant

Guiafenesin 50 mg............................................................................Expectorant

Phenylephrine HCl 2.5mg...................................................................Nasal Decongestant

Cough Suppressant

Expectorant

Nasal Decongestant

Uses temporarily relives these symptoms occuring with cold:

  • nasal congestion
  • cough due to minor throat and bronchial irriatation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

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
  • thyroid disease
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with asthma
  • high blood pressure 
  • diabetes

When using this product, do not use more than directed

Stop use and ask doctor if

  • your child gets nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, comes back, or is accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could b signs of a serious condition.

Keep ot of reach of children. In case of accidental overdose, get medical help or contact  a Poison Control Center right away.

Directions

  • do not use more than  doses in any 24-hour period
  • repeat every 4 hours
  • choose dosage by weight (if weight is not known, choose by age)
  • measure with the dosing device provided. Do not use with any other device.

Age                              Weight                 Dose

2 to under 6 years        24-47 Lbs           1 mL

under 2 years               under 24 Lbs       ask  as doctor

Drug Facts (continued)

Other information

  • store at 20-20 C (68-77 F)
  • alcohol-free
  • oral dosingdevice enclosed

Tamper-Evident: Do not use this product if seal on bottle is torn, broken or missing

Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

Inactive ingradients

citric acid, corn syrup, FD&C yellow #6, flavor, glycerin, guar gum,menthol, methylparaben, propylene glycol, propylparaben, sodium saccharin, sucralose, water

DEFENSOL-ITO 
dextromethorphan, guiafenesin, phenylephrine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-333
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE4 mg  in 1 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP 
FD&C YELLOW NO. 6 
GLYCERIN 
GUAR GUM 
MENTHOL 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
CITRIC ACID MONOHYDRATE 
SACCHARIN SODIUM 
SUCRALOSE 
WATER 
Packaging
#Item CodePackage Description
1NDC:53145-333-151 BOTTLE, DROPPER in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2014
Labeler - Menper Distributors, Inc (101947166)

Revised: 08/2015
 
Menper Distributors, Inc

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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