DEFENSOL-ITO- dextromethorphan, guiafenesin, phenylephrine solution

Defensol-ito by

Drug Labeling and Warnings

Defensol-ito by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each 1 mL, dropperful)                                      Purpose

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

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

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

PURPOSE

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

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.

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
• 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

DO NOT USE

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 OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

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

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

INACTIVE INGREDIENT

Inactive ingradients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEFENSOL-ITO 
dextromethorphan, guiafenesin, phenylephrine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-333
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	4 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-333-15	1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2014

Labeler - Menper Distributors, Inc (101947166)