Leader Mucus Relief Dm Tablet, Extended Release
FDA Label NDC 70000-0722

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Mucus Relief Dm (NDC 70000-0722). 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 active ingredients (in each extended-release tablet), purposes, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Extended-Release Tablet)

Dextromethorphan HBr 30 mg

Guaifenesin 600 mg

Purposes

Cough suppressant

Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep

Do Not Use

  • for children under 12 years of age
  • 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

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

When Using This Product

  • do not use more than directed

Stop Use And Ask A Doctor If

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older:

    1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours

  • children under 12 years of age: do not use

Other Information

  • each tablet contains: magnesium 15 mg
  • do not use if printed foil under cap is broken or missing
  • store between 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

LEADER™

Mucus Relief DM

Guaifenesin, 600 mg

Dextromethorphan Hydrobromide, 30 mg

Extended-Release Tablets

Expectorant | Cough Suppressant

12-Hour Relief

Controls Cough

Thins and Loosens Mucus

Actual Size

COMPARE TO MUCINEX® DM active ingredients

20 EXTENDED-RELEASE TABLETS

100% Money Back Guarantee

* Please review the disclaimer below.