DEFENSOLITO CHILDREN SYRUP- guaifenesin, dextromethorphan hbr liquid

Defensolito Children Syrup by

Drug Labeling and Warnings

Defensolito Children Syrup by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 15mL tsp)

Guaifenesin 100 mg………………………………Expectorant

Dextromethorphan HBr 10 mg……………………Cough suppressant

Purpose 

Expectorant

Cough Suppressant

Uses

Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with the common cold and help loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.

Warnings Do not exceed recommended dosage.

A persistent cough may be a sign of a serious condition. If cough oersistent for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor. 

Do not use:

• in a 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 a pharmacist giving this product.
• this product for persistent or chronic cough such as occur with asthma, or if cough is accompanied ny excessive phlegm (mucus) unless directed by a doctor.

Keep this and all drugs out of the reach of children

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

Directions

do not exceed 6 doses in 24 hours

• Age: Dose
• Children 6 to under 12 years of age: 1 tablespoonful (15mL) every 4 hours
• Children 2 to under 6 years of age: 1/2 tablespoonful (7.5 mL) every 4 hours
• Children under 2 years of age: consult your doctor

Other information 

store this product between 15° to 30° C (59° to 86°F)

Inactive ingredients 

citric acid, D&C red #33, glycerin, methylparaben, natural raspberry flavor, propylene glycol, propylparaben, sucrose and water.

Question? 

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEFENSOLITO CHILDREN SYRUP 
guaifenesin, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
RASPBERRY (UNII: 4N14V5R27W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-008-04	1 in 1 CARTON	02/21/2012
1		120 mL in 1 BOTTLE; 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	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)