Active Ingredients And Purpose
Active ingredient (in each tablet)
Doxylamine succinate 25 mg
Purpose
Nighttime sleep-aid
Leader 44-386
- Manufacturer
- Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
- Effective date
- 2026-07-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- daily-update
- Hydrated at
- 2026-07-17 21:45:46
Key Label Information#
Uses
Use
helps to reduce difficulty in falling asleep
Warnings
Warnings
Directions And Dosage
Directions
adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use
Other Label Information
Other information
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number
Inactive ingredients
dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal display panel
LEADER™ NDC 70000-0567-1 Sleep-Aid Doxylamine Succinate Tablets, 25 mg Nighttime Sleep-Aid One Tablet per Dose 48 TABLETS Actual Size COMPARE TO UNISOM® SLEEPTABS® active ingredient* 100% Money Back Guarantee Leader 44-386
Label Images#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
Products#
- Sleep-Aid
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0567 | 70000-0567-1 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | IACT |
| FD&C BLUE NO. 1 ALUMINUM LAKE | J9EQA3S2JM | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
Complete SPL Sections#
Active ingredient (in each tablet)
Doxylamine succinate 25 mg
Purpose
Nighttime sleep-aid
Use
helps to reduce difficulty in falling asleep
Warnings
Directions
adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use
Other information
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number
Inactive ingredients
dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal display panel
LEADER™ NDC 70000-0567-1 Sleep-Aid Doxylamine Succinate Tablets, 25 mg Nighttime Sleep-Aid One Tablet per Dose 48 TABLETS Actual Size COMPARE TO UNISOM® SLEEPTABS® active ingredient* 100% Money Back Guarantee Leader 44-386
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 8 | 2025-07-19 | full-release | 2026-06-01 01:08:01 |