LEADER MAXIMUM STRENGTH MUCUS RELIEF DM- dextromethorphan hbr, guaifenesin liquid 
CARDINAL HEALTH 110, LLC. DBA LEADER

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Leader Maximum Strength Mucus Relief DM

ACTIVE INGREDIENTS (in each 20 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg


PURPOSE

Cough Suppressant

Expectorant


USE(S)

  • 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

.

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


  • 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

do not use more than directed

STOP USE AND ASK 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 condition.

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.

DIRECTIONS

  • 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

  • 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

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


LEADER MAXIMUM STRENGTH MUCUS RELIEF DM 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0465
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0465-1177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/201904/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drugpart34107/23/201904/29/2022
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(70000-0465)

Revised: 8/2025
 
CARDINAL HEALTH 110, LLC. DBA LEADER