Active Ingredients And Purpose
Active ingredient (in each 5 mL)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide
Purpose
Cough suppressant
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide
Cough suppressant
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
• 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
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
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
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide
Cough suppressant
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
• 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
• each 5 mL contains: sodium 5 mg • store at 20 ° to 25 ° C (68 ° to 77 ° F) • dosing cup provided
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
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
Official SPL XML cached by FDA.report · DailyMed PDF
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2021-06-17 | full-release | 2026-05-31 23:40:52 |
| Folder | File | Date |
|---|---|---|
| otc | a05d5a66-fab7-47e8-b265-d2e19e9ffb13.xml | 2025-11-02 |
| otc | leader-cough-dm-orange-carton-image.jpg | 2025-11-02 |
| otc | c7e0e21c-3ebe-4c97-88db-13613bd11a7d.xml | 2021-06-18 |
| otc | 65250b4d-ea42-454f-96ab-4df365cf465b.xml | 2020-07-03 |
| otc | image-01.jpg | 2020-07-03 |
| otc | 61e3ced1-a614-45c1-a625-d8346df5a312.xml | 2019-12-11 |
| otc | 12-5-16 38421E9C2 only image.jpg | 2016-12-06 |
| otc | 4c99b5e3-cd79-4c54-ae37-3673c836e668.xml | 2016-12-06 |