COSEDAL DROPS- dextromethorphan hbr, guaifenesin liquid

Cosedal Drops by

Drug Labeling and Warnings

Cosedal Drops 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 ingredients

Dextromethorphan HBR

Guaifenesin

PURPOSE

Purpose

Cough Suppressant

Expectorant

INDICATIONS & USAGE

Uses

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

WARNINGS

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 reoccur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

DO NOT USE

Do not use:

• This product for persistent or chronic cough, such as occurs with smoking, asthma, 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.

PREGNANCY OR BREAST FEEDING

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.

DOSAGE & ADMINISTRATION

Directions

Do not exceed 6 doses in 24 hours.

          age  dose

Adults and children                                              2 teaspoonfuls (10 mL)

12 years of age and over....................................... every 4 hours

Children 6 to                                                       under 1 teaspoonful (5 mL)

12 years of age..................................................... every 4 hours

Children 2 to                                                       under 1/2 teaspoonful (2.5 mL)

6 years of age....................................................... every 4 hours

Children under 2 years of age.................................. consult your doctor

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

Inactive ingredients Citric acid, D&C red #33, glycerin, methylparaben, natural raspberry flavor, propylene glycol, propylparaben , purified water, sucrose

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COSEDAL DROPS 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-059
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 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: 53145-059-02	1 in 1 CARTON
1		60 mL in 1 BOTTLE, DROPPER

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)