Sleep Aid

Manufacturer
Meijer Distribution Inc | LNK International, Inc.
Effective date
2026-03-27
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:51:53

Label at a glance#

ProductSleep Aid
Active ingredientDOXYLAMINE SUCCINATE
Label structure9 sections

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Doxylamine succinate 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking

  • sedatives 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.

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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41250-986-22

Compare to
Unisom® SleepTabs®

active ingredient*

Meijer®

Sleep Aid

DOXYLAMINE SUCCINATE TABLETS 25 mg
NIGHTTIME SLEEP-AID

Helps to reduce difficulty falling asleep
one tablet per dose

48 Tablets

Actual
Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE 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     REV0123F38622

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com

Meijer 44-386
Meijer 44-386

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN11
1101446doxylamine succinate 25 MG Oral TabletSCD11

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130713733983648GTIN-13: 0713733983648
EAN-13: 0713733983648
GTIN-12: 713733983648
UPC-A: 713733983648
GTIN storage (14 digits): 00713733983648
meijer-44-386-1.jpg

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
41250-986-22Sleep Aid3 in 1 CARTONTABLET311
41250-986-22Sleep Aid16 in 1 BLISTER PACKTABLET1611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41250-986-22EA - Each41250-986f6ba7eb9-8c4f-4c2f-a2bd-cb54896e5ea412024-01-04

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-98641250-986-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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 44.

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
A040564-001DOXYLAMINE SUCCINATEDOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27c2088c7a36db…
2026-09-14 22:38:342026-08A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2784e616aacf4f…
2026-08-18 06:07:402026-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273f01610625f2…
2019-09-15 20:21 UTC2019-09A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273a93d1ddd44b…

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
Sleep AidDOXYLAMINE SUCCINATEMeijer Distribution Inc96a7c284-4666-4dac-b71e-9433f62580ad2026-03-27WarningsExact identifier
ndc (package): 41250-986-22
ndc (product): 41250-986
ndc11 (package): 41250098622
spl id: 34be9734-68c0-453f-afc4-7103d2e9fc48
spl set id: 96a7c284-4666-4dac-b71e-9433f62580ad

Reported adverse events (FAERS/openFDA)#

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