COSEDAL DROPS- dextromethorphan hbr, 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

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

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:

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.

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
12 years of age and over	2 teaspoonfuls (10 mL) every 4 hours
Children 6 to under 12 years of age	1 teaspoonful (5 mL) every 4 hours
Children 2 to under 6 years of age	1/2 teaspoonful (2.5 mL) 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, propylene glycol, propylparaben, raspberry falvor, sucrose, water

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53145-059-02	1 in 1 CARTON	02/21/2012
1		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)

Revised: 8/2021

Document Id: 43d2b7ca-a0d8-4505-9940-7360d189ebc5

Set id: 1241d249-ea3b-4d2b-87ed-835d6a2d286a

Version: 4

Effective Time: 20210809

Menper Distributors, Inc.