Mucus Relief Dm
FDA Label NDC 68210-4153

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 68210-4153). 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

  • temporarily relieves cough due to minor throat and
    bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial
    secretions to rid the bronchial passageways of
    bothersome mucus and 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

  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
  • adults and children 12 years of age and over: take 1 softgel every 4 hours
  • children under 12 years of age: do not use

Other Information

  • store at 25°C (77°F); excursions permitted between 15°- 30°C (59° - 86°F)
  • keep in a dry place and do not expose to heat

Inactive Ingredients

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

Questions Or Comments?

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