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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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)


WARNINGS

.

DO NOT USE

ASK A DOCTOR BEFORE USE IF


WHEN USING THIS PRODUCT

do not use more than directed

STOP USE AND ASK DOCTOR IF


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







OTHER INFORMATION

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 Product07/23/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/23/2019
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Revised: 1/2022
Document Id: a339e9ce-bc00-4467-ad90-d8cb333ee0a7
Set id: 22efdf17-92c7-4670-8470-4f99d24ce7de
Version: 3
Effective Time: 20220111
 
CARDINAL HEALTH 110, LLC. DBA LEADER