LEADER COUGH DM- dextromethorphan polistirex suspension, extended release

Leader Cough by

Drug Labeling and Warnings

Leader Cough by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• mL = milliliter

• 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

D&C Red #30 aluminum lake, FD&C Blue #1, flavor, 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?

call 1-800-719-9260

You may also report side effects to this phone number.

Package/Label Principal Display Panel

Cough DM

Dextromethorphan Polistirex

Extended-Release Oral Suspension

Cough Suppressant

Day or Night

Grape

Flavored Liquid

12 Hour Cough Relief

COMPARE TO DELSYM® active ingredient

Dosing Cup Included

Alcohol-Free

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

100% Money Back Guarantee

3 FL OZ (89mL)

INGREDIENTS AND APPEARANCE

LEADER COUGH  DM
dextromethorphan polistirex suspension, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0302
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0302-1	1 in 1 CARTON	06/06/2017
1		89 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091135	06/06/2017

Labeler - Cardinal Health (097537435)