Mucus Relief Dm
FDA Label NDC 68210-1390

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Mucus Relief Dm (NDC 68210-1390). 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 other, otc - purpose, uses, do not use, ask doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredient (in each softgel)Purposes
Guaifenesin 400mgExpectorant
Dextromethorphan HBr 20mgCough Suppressant

Uses

  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive

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 Doctor Before Use If You Have

  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

When Using This Product

  • do not exceed recommended dosage
  • do not use for more than 7 days

Stop Use And Ask A Doctor If

  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older:

  • Take with a full glass of water.
  • Take 1 softgel every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • Children under 12 years of age: do not use

Other Information

  • store at 25°C (77°F) excursions between 15° - 30°C (59° - 86°F)
  • keep in a dry place and do not expose to heat
  • you may report side effects to 1-888-333-9792

Inactive Ingredients

 gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Mucus Relief DM

COUGH

GUAIFENESIN 400 mg/EXPECTORANT
DEXTROMETHORPHAN HBr 20 mg/COUGH SUPPRESSANT

DISSOLVES QUICKLY

Controls cough
Thins & loosens mucus

* Please review the disclaimer below.