LEADER COUGH DM- dextromethorphan polistirex suspension, extended release 
Cardinal Health 110, LLC. dba Leader

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Cardinal Health Cough DM Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Uses

temporarily relieves

cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
the impulse to cough to help you get to sleep

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.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Ask a doctor before use if you have

chronic cough that lasts as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. 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 (1-800-222-1222).

Directions

shake bottle well before use
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor

adults and children 12 years of age

and over

10 mL every 12 hours, not to exceed 20 mL in 24 hours

children 6 to under 12 years of age

5 mL every 12 hours, not to exceed 10 mL in 24 hours

children 4 to under 6 years of age

2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

children under 4 years of age

do not use

Other information

each 5 mL contains: sodium 5 mg
store at 20° to 25°C (68° to 77°F)
dosing cup provided

Inactive ingredients

artificial grape flavor, D&C Red #30 aluminum lake, FD&C Blue #1 aluminum lake, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Day or Night

Cough DM

Dextromethorphan Polistirex Extended-Release Oral Suspension

Cough Suppressant

Grape Flavored Liquid

12 Hour Cough Relief

Alcohol-Free

Dosing Cup Included

COMPARE TO DELSYM® active ingredient

100% Money Back Guarantee

Contains Sodium Metabisulfite, a Sulfite That May Cause Allergic-Type Reactions

3 FL OZ (89 mL)

DO NOT USE IF CARTON IS OPENED OR PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

Cough DM Carton Image 1
Cough DM Carton Image 2
LEADER COUGH  DM
dextromethorphan polistirex suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ACETATE (UNII: 32K497ZK2U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
SUCROSE (UNII: C151H8M554)  
TARTARIC ACID (UNII: W4888I119H)  
TRAGACANTH (UNII: 2944357O2O)  
TRIACETIN (UNII: XHX3C3X673)  
XANTHAN GUM (UNII: TTV12P4NEE)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0302-11 in 1 CARTON06/06/2017
189 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113506/06/2017
Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 6/2021
Document Id: 705b6716-957d-40f2-b881-8fd36f0ea549
Set id: a07b70d0-3842-4ea6-abb4-95b4638d5e55
Version: 4
Effective Time: 20210617
 
Cardinal Health 110, LLC. dba Leader