dometuss-dm

dometuss-dm
SPL v4
SPL
SPL Set ID 7c4e7eca-0dc2-4b49-bda5-d61770ef9aca
Route
oral
Published
Effective Date 2024-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (200 mg) dextromethorphan (30 mg)
Inactive Ingredients
citric acid monohydrate d&c red no. 33 fd&c blue no. 1 glycerin methylparaben propylene glycol propylparaben water sodium citrate, unspecified form sucralose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-01-21

Purpose

Expectorant Cough suppressant

Description

Guaifenesin 200mg Dextromethorphan HBr 30 mg


Medication Information

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.
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.
Purpose

Expectorant

Cough suppressant

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.

Description

Guaifenesin 200mg Dextromethorphan HBr 30 mg

Drug Facts

Guaifenesin 200mg

Dextromethorphan HBr 30 mg

Questions Or Comments?

Please call (787) 767-3246

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.
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

If Pregnant Or Breast Feeding

as a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

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.
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.
Purpose

Expectorant

Cough suppressant

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 (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.

Drug Facts

Guaifenesin 200mg

Dextromethorphan HBr 30 mg

Questions Or Comments? (Questions or comments?)

Please call (787) 767-3246

Do Not Use This Product (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.
Dometuss Dm Product Label (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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

as a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)