Dometuss-dm Liquid
FDA Label NDC 53809-201

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-dm (NDC 53809-201). 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 tsp), purpose, keep out of reach of children., uses, warnings, do not use this product, if pregnant or breast-feeding, directions, 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 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

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