Nighttime Sleep-Aid — v3

Nighttime Sleep-Aid

8 Views

Version

v3

Effective date

September 23, 2025

Original packager

Yes

Sections captured

17

Identifiers

Document ID
ef20e7d5-02fa-46b1-b065-8eb0aca5ea19
Set ID
8b85812e-33a3-4534-bfba-ee4502d11d34
Application numbers
ANDA040564
Product NDCs
30142-366
Package NDCs
30142-366-27
Original packager NDCs

Names & Manufacturers

Brand names
Nighttime Sleep-Aid
Generic names
DOXYLAMINE SUCCINATE
Manufacturer names
Kroger Company
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
DOXYLAMINE SUCCINATE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
1101446
UNII
V9BI9B5YI2
UPC
0041260012303

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each tablet) Doxylamine succinate 25 mg
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs
Do Not Use (1)

Sequence 1

Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep
Dosage And Administration (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Indications And Usage (1)

Sequence 1

Use helps to reduce difficulty in falling asleep
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

Principal Display Panel Kroger ®h ealth NDC 30142-366-27 COMPARE TO THE ACTIVE INGREDIENT IN UNISOM® SLEEPTABS®* ONE TABLET PER DOSE NightTime Sleep-Aid Doxylamine Succinate Tablet, 25 mg NightTime Sleep-Aid NOT FOR TREATING COLD OR PAIN 32 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 *Unisom® is a registered trademark of Chattem, Inc. 50844 REV0123C38627 DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 ‡OUR PHARMACIST RECOMMENDED Our Brands. Our Guarantee. Love It or Your Money Back. www.kroger.com For More Product Information, Scan UPC Using Your Kroger App or Call 800-632-6900 Kroger 44-386 Kroger 44-386
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Nighttime sleep-aid
Questions (1)

Sequence 1

Questions or comments? 1-800-632-6900
Spl Product Data Elements (1)

Sequence 1

Nighttime Sleep-Aid Doxylamine succinate DOXYLAMINE SUCCINATE DOXYLAMINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO 44;386
Stop Use (1)

Sequence 1

Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.
Storage And Handling (1)

Sequence 1

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
Warnings (1)

Sequence 1

Warnings Do not use 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 glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
When Using (1)

Sequence 1

When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime

OpenFDA raw payload

{'application_number': ['ANDA040564'],
 'brand_name': ['Nighttime Sleep-Aid'],
 'generic_name': ['DOXYLAMINE SUCCINATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Kroger Company'],
 'package_ndc': ['30142-366-27'],
 'product_ndc': ['30142-366'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['1101446'],
 'spl_id': ['ef20e7d5-02fa-46b1-b065-8eb0aca5ea19'],
 'spl_set_id': ['8b85812e-33a3-4534-bfba-ee4502d11d34'],
 'substance_name': ['DOXYLAMINE SUCCINATE'],
 'unii': ['V9BI9B5YI2'],
 'upc': ['0041260012303']}