Dosage and administration
adults: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor do not give to children under 12 years of age
adults: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor do not give to children under 12 years of age
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20º-25ºC (68º-77ºF) see end flap for expiration date and lot number
Doxylamine succinate 25 mg
Nighttime sleep-aid
helps to reduce difficulty in falling asleep
taking any other drugs.
sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Call 1-800-426-9391
8:30 AM-4:00 PM ET, Monday-Friday
RITE
AID
PHARMACY®
*Compare to the active ingredient
in Unisom® Sleep Tabs®
sleep aid
doxylamine succinate 25 mg
nighttime sleep aid
helps to reduce
difficulty falling asleep
safe & effective
go to sleep fast!
just one tablet per dose
easy to swallow
actual size
easy to swallow
48 TABLETS
TAMPER EVIDENT: DO NOT USE IF
CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Chattem,
Inc., owner of the registered trademark Unisom®
SleepTabs®.
50844 REV0513A38622
DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | 3 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11822-0386 | 11822-0386-2, 11822-0386-7 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, EXTENDED RELEASE / ORAL | 360 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, COATED / ORAL | 333.3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | PASTE, DENTIFRICE / DENTAL | 48.36 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, FILM COATED / ORAL | 1075 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | PASTILLE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040564-001 | DOXYLAMINE SUCCINATE | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 3a93d1ddd44b… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 818ec1f0-8a6c-49ca-bc4c-390af198f051 | 99883c0a-4152-440e-b626-4af6ed07a2ff | 2019-11-11 | Warnings | 818ec1f0-8a6c-49ca-bc4c-390af198f051 99883c0a-4152-440e-b626-4af6ed07a2ff |
Adverse event summaries are temporarily unavailable. Other product information remains available.