Dometuss-dmx Liquid
FDA Label NDC 53809-203

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Domel Laboratories for the product Dometuss-dmx (NDC 53809-203). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug factsactive ingredients (in each 5 ml teaspoonful) contains, purpose, keep this and all drugs out of the reach of children., uses, warnings - do not use, ask a doctor before use if you have, if pregnant or breast-feeding, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredients (In Each 5 Ml Teaspoonful) Contains

Guaifenesin 200mg

Dextromethorphan HBr, USP 30 mg

Phenylephrine HCL, USP 10 mg

Purpose

Expectorant

Cough suppressant

Nasal decongestant

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.

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

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.

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

If Pregnant Or Breast-Feeding

as a health professional before use.

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.

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

 

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.

Other Information

• Store at 15°-30° C (59°-86°F)

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

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