DEFENSOL ADULT SYRUP- guaifenesin, dextromethorphan hbr liquid

Defensol Adult Syrup by

Drug Labeling and Warnings

Defensol Adult 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 10mL tsp)

Dextromethorphan HBr 20 mg……………………Cough suppressant

Guaifenesin 200 mg………………………………Expectorant

Purposes

Cough Suppressant

Expectorant

Uses

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

Warnings

Do not exceed recommended dosage.

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

Do not use:

• This product for persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
• if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If you are pregnant or breast-feeding,

ask a health professional before use.

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
• Adults and children12 years of age and over: 2 teaspoonfuls (10 mL) every 4 hours
• Children under 12 years of age: Do not use

Other information

• Store this product between 15°-30°C (59°-86°F)

Inactive ingredients

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

Question?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEFENSOL ADULT SYRUP 
guaifenesin, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-039
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-039-04	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)