Leader Cough DM

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:41:21

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Uses

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

Warnings

Directions And Dosage

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 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 Label Information

Inactive ingredients

D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, glycerin, high fructose corn syrup, methylparaben, natural and artificial orange flavor, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions or comments?

Package/Label Principal Display Panel

LEADER ™ Day or Night Cough DM Dextromethorphan Polistirex Extended-Release Oral Suspension Cough Suppressant Orange Flavored Liquid COMPARE TO DELSYM ® active ingredient 12 Hour Relief Alcohol-Free Dosing Cup Included 100% Money Back Guarantee Contains Sodium Metabisulfite, a Sulfite That May Cause Allergic-Type Reactions 3 FL OZ (89 mL) DO NOT USE IF CARTION IS OPENED OR PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

Label Images

leader-cough-dm-orange-carton-image
leader-cough-dm-orange-carton-image

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, glycerin, high fructose corn syrup, methylparaben, natural and artificial orange flavor, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER ™ Day or Night Cough DM Dextromethorphan Polistirex Extended-Release Oral Suspension Cough Suppressant Orange Flavored Liquid COMPARE TO DELSYM ® active ingredient 12 Hour Relief Alcohol-Free Dosing Cup Included 100% Money Back Guarantee Contains Sodium Metabisulfite, a Sulfite That May Cause Allergic-Type Reactions 3 FL OZ (89 mL) DO NOT USE IF CARTION IS OPENED OR PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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27687

Older Hydrated Versions

VersionEffective dateSourceHydrated
42021-06-17full-release2026-05-31 23:40:52

Legacy File Index

FolderFileDate
otca05d5a66-fab7-47e8-b265-d2e19e9ffb13.xml2025-11-02
otcleader-cough-dm-orange-carton-image.jpg2025-11-02
otcc7e0e21c-3ebe-4c97-88db-13613bd11a7d.xml2021-06-18
otc65250b4d-ea42-454f-96ab-4df365cf465b.xml2020-07-03
otcimage-01.jpg2020-07-03
otc61e3ced1-a614-45c1-a625-d8346df5a312.xml2019-12-11
otc12-5-16 38421E9C2 only image.jpg2016-12-06
otc4c99b5e3-cd79-4c54-ae37-3673c836e668.xml2016-12-06