FDA.reportPublic FDA data

Amerisource Bergen Sleep Aid Tablets Drug Facts

Manufacturer
Amerisource Bergen
Effective date
2024-07-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:15:12

Label at a glance#

Productgood neighbor pharmacy sleep 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

• store at 20°-25°C (68°-77°F) • keep carton. It contains important information.

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

  • a 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

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)
  • 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?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Unisom ® SleepTabs® active ingredient

Good Neighbor Pharmacy®

Sleep Aid Tablets

doxylamine succinate tablets, 25 mg

Nighttime Sleep-Aid

Clinically Tested, Proven Effective

One Tablet Per Dose

32 Tablets

actual size

sleep aid tablets
sleep aid tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN3
1101446doxylamine succinate 25 MG Oral TabletSCD3

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
46122-763-51good neighbor pharmacy sleep aid32 in 1 CARTONTABLET323
46122-763-51good neighbor pharmacy sleep aid1 in 1 BLISTER PACKTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-763GOOD NEIGHBOR PHARMACY SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [AMERISOURCE BERGEN]32 package rows20240713_87543aa8-3b48-4fd9-9cfd-161cadcb3abb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-763-51EA - Each46122-763cbdbf220-feb5-44cc-89e0-3a1801b74adf12024-11-05

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-76346122-763-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT

Source Document#

Source XML

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
9152a3ae-88a8-4337-9076-8138237ff20b87543aa8-3b48-4fd9-9cfd-161cadcb3abb2024-07-12WarningsExact identifier
spl id: 9152a3ae-88a8-4337-9076-8138237ff20b
spl set id: 87543aa8-3b48-4fd9-9cfd-161cadcb3abb

Reported adverse events (FAERS/openFDA)#

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