FDA.reportPublic FDA data

Unisom SleepTabs

Manufacturer
Chattem, Inc.
Effective date
2026-01-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:32:50

Label at a glance#

ProductUnisom SleepTabs
Active ingredientDOXYLAMINE SUCCINATE
Label structure9 sections

Indications and uses

helps to reduce difficulty in falling asleep

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Unisom®  SleepTabs®

Doxylamine succinate tablets Nighttime Sleep-Aid

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Doxylamine succinate 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • helps to reduce difficulty in falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in children under 12 years of age
  • with any other product containing doxylamine
  • unless you have time for a full night’s sleep

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • sedative or any other sleep-aid
  • tranquilizers
  • any other antihistamines
  • any other drugs

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • take only at bedtime

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • Store at 20º to 25ºC (68 º-77 ºF)
  • Keep carton. It contains important information

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments: 1-866-844-2798 Monday- Friday 8am-6pm EST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unisom Sleeptabs
Doxylamine succinate
25 mg

Nighttime Sleep-Aid
32 Tablets

Unisom Sleeptabs Doxylamine succinate 25 mg Nighttime Sleep-Aid 32 TabletsUnisom Sleeptabs Doxylamine succinate 25 mg Nighttime Sleep-Aid 32 Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN5
1101448Unisom SleepTabs 25 MG Oral TabletPSN5
1101448doxylamine succinate 25 MG Oral Tablet [Unisom]SBD5
1101446doxylamine succinate 25 MG Oral TabletSCD5
1101448Unisom 25 MG Oral TabletSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0063-5Unisom SleepTabs16 in 1 BLISTER PACKTABLET165
41167-0063-5Unisom SleepTabs1 in 1 CARTONTABLET15
41167-0063-6Unisom SleepTabs32 in 1 BOTTLE, PLASTICTABLET325
41167-0063-6Unisom SleepTabs1 in 1 CARTONTABLET15
41167-0063-7Unisom SleepTabs48 in 1 BOTTLE, PLASTICTABLET485
41167-0063-7Unisom SleepTabs1 in 1 CARTONTABLET15
41167-0063-8Unisom SleepTabs80 in 1 BOTTLE, PLASTICTABLET805
41167-0063-8Unisom SleepTabs1 in 1 CARTONTABLET15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-006341167-0063-5, 41167-0063-6, 41167-0063-7, 41167-0063-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040167-001DOXYLAMINE SUCCINATEDOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18

Observed Orange Book product history#

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1884e616aacf4f…
2026-08-18 06:07:402026-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183f01610625f2…
2019-09-15 20:21 UTC2019-09A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18f41ea6bd6efb…

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unisom SleepTabsDOXYLAMINE SUCCINATEChattem, Inc.f591d52f-5610-4517-a96f-1ed63deb00bc2026-01-14WarningsExact identifier
ndc (package): 41167-0063-8
ndc (package): 41167-0063-6
ndc (package): 41167-0063-7
ndc (package): 41167-0063-5
ndc (product): 41167-0063
ndc11 (package): 41167006308
ndc11 (package): 41167006306
ndc11 (package): 41167006307
ndc11 (package): 41167006305
spl id: 32b4f344-3f75-4804-b8cb-800fe2b508c0
spl set id: f591d52f-5610-4517-a96f-1ed63deb00bc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.