COSEDAL DROPS- dextromethorphan hydrobromide and guaifenesin liquid 
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 ingredients

Dextromethorphan HBR

Guaifenesin

Purpose

Cough Suppressant

Expectorant

Uses

Warnings

Do not exceed recommended dosage.

Do not use:

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 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 information

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

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

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

Cosedal Drops Label

COSEDAL DROPS 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-059
Route of Administration ORAL DEA Schedule     
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)

Revised: 9/2013
Document Id: 5214881e-6a73-4631-af49-cb3f55439a84
Set id: 1241d249-ea3b-4d2b-87ed-835d6a2d286a
Version: 3
Effective Time: 20130919
 
Menper Distributors, Inc.