TUSSIN DM- dextromethorphan hbr, guaifenesin solution 
Cardinal Health 110, LLC. DBA Leader

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Leader 44-030

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough suppressant
Expectorant

Uses

Warnings

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 a doctor before use if you have

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

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a 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

Other information

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-800-426-9391

Principal Display Panel

LEADER♥

NDC 70000-0628-1

Maximum Strength

Tussin DM
Cough & Chest
Congestion DM

Dextromethorphan HBr
Guaifenesin

Cough Suppressant
Expectorant

Menthol-Berry
Flavor

Ages 12 Years
and Over

Controls Cough

Relieves Chest
Congestion

Thins & 
Loosens 
Mucus

COMPARE TO
ROBITUSSIN®
MAXIMUM STRENGTH
COUGH + CHEST 
CONGESTION DM

active ingredients*

100% Money Back Guarantee

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by GlaxoSmithKline
Consumer Healthcare Holdings (US) LLC, owner of the registered
trademark Robitussin® Maximum Strength Cough + Chest
Congestion DM.

50844    REV0123A03036

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DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
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Leader 44-030

Leader 44-030

TUSSIN DM 
dextromethorphan hbr, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0628
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorred (MAROON) Score    
ShapeSize
FlavorMENTHOL, BERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0628-21 in 1 CARTON03/16/2023
1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:70000-0628-11 in 1 CARTON03/16/2023
2118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/16/2023
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305manufacture(70000-0628) , pack(70000-0628)

Revised: 7/2024
Document Id: adb46bf9-7609-4d71-b044-c67c46405a84
Set id: c63ef4a0-bbc2-4e6f-9354-225e494314bc
Version: 5
Effective Time: 20240701
 
Cardinal Health 110, LLC. DBA Leader