DEFENSOL-ITO- dextromethorphan, guiafenesin, phenylephrine solution 
Menper Distributors, Inc

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.

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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:

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

When using this product, do not use more than directed

Stop use and ask doctor if

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

Directions

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

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 Label

DEFENSOL-ITO 
dextromethorphan, guiafenesin, phenylephrine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-333
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE4 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
GUAR GUM (UNII: E89I1637KE)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-333-151 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2014
Labeler - Menper Distributors, Inc (101947166)

Revised: 8/2015
Document Id: f94a0a87-0b80-4e16-9f46-5fb5456976e9
Set id: a7c7a60d-d49f-4239-92f7-714eac7eb0c5
Version: 5
Effective Time: 20150812
 
Menper Distributors, Inc