Dometuss-dmx

Dometuss-dmx
SPL v4
SPL
SPL Set ID 6949e1c6-df1c-451b-a1e2-9199415440f4
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) Phenylephrine (10 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, USP 30 mg Phenylephrine HCL, USP 10 mg

Purpose

Expectorant Cough suppressant Nasal decongestant


Medication Information

Purpose

Expectorant

Cough suppressant

Nasal decongestant

Description

Guaifenesin 200mg Dextromethorphan HBr, USP 30 mg Phenylephrine HCL, USP 10 mg

Uses
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Temporarily relieves these symptoms occuring with a cold: nasal congestion, cough due to minor throat and bronchial irritation
Directions

  Do not exceed recommended dosage

Do not take more than 4 doses in any 24-hour period

 

 
 age  dose
 Adults and children 12 years of age and older  1 teaspoon every 6 hours
 Children under 12 years of age  ask a doctor

 

Drug Facts

Guaifenesin 200mg

Dextromethorphan HBr, USP 30 mg

Phenylephrine HCL, USP 10 mg

Other Information

• Store at 15°-30° C (59°-86°F)

Inactive Ingredients

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

Warnings Do Not Use
  • 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.
Questions Or Comments?

Please call (787) 767-3246

Dometuss Dmx Product Label

NDC 53809-203-01

DOMETUSS-DMX

COUGH SUPPRESSANT/EXPECTORANT/NASAL DECONGESTANT

Alcohol and Sugar

FREE

Grape Flavor

1 Fl. Oz. (30 mL)

Rev: 12/12

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

LOT#:/EXP.DATE:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

Stop Use and Ask A Doctor If
  • You get nervous, dizzy, or sleepless
  • Symptoms do not get better within 7 days or are accompanied by a fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding

as a health professional before use.

Ask A Doctor Before Use If You Have
  • Heart Disease
  • High Blood Pressure
  • Thyroid Disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Cough that lasts or is chronic such as bronchitis or emphysema
Keep This and All Drugs Out of the 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 drain bronchial tubes
  • Temporarily relieves these symptoms occuring with a cold: nasal congestion, cough due to minor throat and bronchial irritation
Purpose

Expectorant

Cough suppressant

Nasal decongestant

Directions

  Do not exceed recommended dosage

Do not take more than 4 doses in any 24-hour period

 

 
 age  dose
 Adults and children 12 years of age and older  1 teaspoon every 6 hours
 Children under 12 years of age  ask a doctor

 

Drug Facts

Guaifenesin 200mg

Dextromethorphan HBr, USP 30 mg

Phenylephrine HCL, USP 10 mg

Other Information (Other information)

• Store at 15°-30° C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

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

Warnings Do Not Use (Warnings - Do not use)
  • 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.
Questions Or Comments? (Questions or comments?)

Please call (787) 767-3246

Dometuss Dmx Product Label (DOMETUSS-DMX product label)

NDC 53809-203-01

DOMETUSS-DMX

COUGH SUPPRESSANT/EXPECTORANT/NASAL DECONGESTANT

Alcohol and Sugar

FREE

Grape Flavor

1 Fl. Oz. (30 mL)

Rev: 12/12

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

LOT#:/EXP.DATE:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • You get nervous, dizzy, or sleepless
  • Symptoms do not get better within 7 days or are accompanied by a fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.

These could be signs of a serious condition.

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

as a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • Heart Disease
  • High Blood Pressure
  • Thyroid Disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Cough that lasts or is chronic such as bronchitis or emphysema
Keep This and All Drugs Out of the Reach of Children. (KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.)

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


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Raw Label Data

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