Your browser does not support JavaScript! COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

COSEDAL DROPS (dextromethorphan hbr, guaifenesin) liquid
[Menper Distributors, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53145-059
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE 
D&C RED NO. 33 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
RASPBERRY 
SUCROSE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-059-021 in 1 CARTON
160 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/21/2012
Labeler - Menper Distributors, Inc. (101947166)

Revised: 9/2013
 
Menper Distributors, Inc.

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services