Leader Maximum Strength Mucus Relief DM

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Effective date
2022-01-11
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:18:03

Label at a glance#

ProductLeader Maximum Strength Mucus Relief DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections

Dosage and administration

do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Adults & children 12 years & older: 20 mL every 4 hours Children under 12 years of age: Do not use

Storage and handling

each 20 mL contains: potassium 20 mg, sodium 20 mg store between 15-30°C (59-86°F) do not refrigerate dosing cup provided

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg


PURPOSE

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant


USE(S)

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

.

DO NOT USE

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION


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

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

do not use more than directed

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION


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

IF PREGNANT OR BREAST-FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • Adults & children 12 years & older: 20 mL every 4 hours
  • Children under 12 years of age: Do not use






OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each 20 mL contains: potassium 20 mg, sodium 20 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

citric acid anhydrous, dextrose, D&C red # 33, FD&C Red #40,  flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™
NDC 70000-0465-1


Maximum Strength
Mucus
Relief DM


Dextromethorphan HBr, 20 mg
Guaifenesin, 400 mg

Cough Suppressant / Expectorant


For Ages 12 & Over
Multi-Symptom

Relieves Chest Congestion    
Controls Cough   

Thins and loosens Mucus

COMPARE TO MUCINEX FAST MAX DM MAX active ingredients*
6 FL OZ (177 mL)

119
119


FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0465-12025-08-22C16284748780-11030e365-0178-111a-e063-dadaa90a10e2Leader Maximum Strength Mucus Relief DM
70000-0465-12024-01-30C16284748780-11030e365-0178-111a-e063-dadaa90a10e2Leader Maximum Strength Mucus Relief DM

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0465LEADER MAXIMUM STRENGTH MUCUS RELIEF DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CARDINAL HEALTH 110, LLC. DBA LEADER]3Legacy NDC20220112_22efdf17-92c7-4670-8470-4f99d24ce7de.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0465-1ML - Milliliter70000-04659877dbed-11ee-42ff-96ef-165fa516f65012020-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-046570000-0465-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0f325eca-5a9b-4477-95b3-158501d7be6f22efdf17-92c7-4670-8470-4f99d24ce7de2025-08-22WarningsExact identifier
spl set id: 22efdf17-92c7-4670-8470-4f99d24ce7de

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.