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DOMETUSS-DM

Medically reviewed on January 22, 2018.

Dosage form: liquid
Ingredients: GUAIFENESIN 200mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 30mg in 5mL
Labeler: Domel Laboratories
NDC Code: 53809-201

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.

DOMETUSS-DM

Drug Facts
Active ingredients (in each 5 mL tsp)

Guaifenesin 200mg

Dextromethorphan HBr 30 mg

Purpose

Expectorant

Cough suppressant

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves coughs due to minor throat and bronchial irritation as may occur with a cold.

Warnings
  • Do not exceed recommended dosage.
  • A persistant cough may be a sign of a serious condition; if cough persists for more than one week, tend to recur, or is accompanied by fever, rash, or persistant headache, consult a doctor.

Do not use this product
  • for persistant 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 Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; if you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.

If pregnant or breast-feeding

as a health professional before use.

Directions

Do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.

 

 
 Adults and children 12 years of age and over Take 1 teaspoonful (5 mL) every 6 hours
 Children 6 to under 12 years of age Take 1/2 teaspoonful (2.5 mL) every 6 hours
 Children under 6 years of age Ask a doctor

 

Other Information

• store at room temperature 15°-30°C (59°-86°F).

Tamper Evident: Do not use if there is evidence of tampering.

Inactive ingredients

Artificial grape flavor, citric acid, D&C red #33, FD&C blue #1, glycerin, methyl paraben (as preserative), propylene glycol, propyl paraben (as preseratie, purified water, sodium citrate, sucralose.

Questions or comments?

Please call (787) 767-3246

DOMETUSS-DM product label

NDC 53809-201-01

DOMETUSS-DM

EXPECTORANT/COUGH SUPPRESSANT

Alcohol and Sugar

FREE

Grape Flavoe

1 Fl. Oz.

Rev: 10/13

Lot#:/EXP.DATE:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

DOMETUSS-DM 
guaifenesin, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-201
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
FD&C BLUE NO. 1 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorgrapeImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53809-201-0130 mL in 1 BOTTLE
2NDC:53809-201-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/21/2016
Labeler - Domel Laboratories (808198837)
Registrant - Domel Laboratories (808198837)

 
Domel Laboratories

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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