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

Description

Guaifenesin 200mg Dextromethorphan HBr 30 mg

Purpose

Expectorant Cough suppressant


Medication Information

Purpose

Expectorant

Cough suppressant

Description

Guaifenesin 200mg Dextromethorphan HBr 30 mg

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.
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

 

Drug Facts

Guaifenesin 200mg

Dextromethorphan HBr 30 mg

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

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

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

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.
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

 

Drug Facts

Guaifenesin 200mg

Dextromethorphan HBr 30 mg

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.

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

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