FDA.reportPublic FDA data

meijer NIGHTTIME Sleep Aid SOFTGEL

Manufacturer
Meijer, Inc.
Effective date
2025-02-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:56:58

Label at a glance#

Productmeijer NIGHTTIME Sleep Aid SOFTGEL
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

• for relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

• take only one dose (2 softgels) per day (24 hours)  adults and children 12 years and over  take 2 softgels at bedtime if needed or as directed by a doctor  children under 12 years  do not use

Storage and handling

• store at room temperature between 20°-25°C (68°-77°F) • protect from light, heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

• for relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use  • for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have  • glaucoma  • heart diseases
• a breathing problem such as emphysema, asthma, or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid

When using this product  • avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

• take only one dose (2 softgels) per day (24 hours)

 adults and children 12 years and over take 2 softgels at bedtime if needed or as directed by a doctor
 children under 12 years do not use

Other information

STORAGE AND HANDLING SECTION

• store at room temperature between 20°-25°C (68°-77°F)
• protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue no.1, FD&C red no.40, gelatin(bovine), glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol 400, povidone K-30, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

COMPARE TO VICKS® ZZZQUIL™ LIQUICAPS™ ACTIVE INGREDIENT*

HELPS FALL ASLEEP

Not for Treating Pain, Cold or Flu

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
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 The Procter & Gamble Co., owner of the trademarks Vicks®, ZzzQuil™, and LiquiCaps™.

DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544

WWW.MEIJER.COM

PRODUCT OF UNITED ARAB EMIRATES

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIGHTTIME Sleep AidNIGHTTIME Sleep Aid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0779-4meijer NIGHTTIME Sleep Aid SOFTGEL2 in 1 CARTONCAPSULE, LIQUID FILLED23
79481-0779-4meijer NIGHTTIME Sleep Aid SOFTGEL12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED123
79481-0779-8meijer NIGHTTIME Sleep Aid SOFTGEL4 in 1 CARTONCAPSULE, LIQUID FILLED43
79481-0779-8meijer NIGHTTIME Sleep Aid SOFTGEL12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0779MEIJER NIGHTTIME SLEEP AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MEIJER, INC.]3Current NDC, 4 package rows20250313_1bede4cd-bf55-8b84-e063-6394a90aa5c9.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79481-077979481-0779-4, 79481-0779-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN TYPE B BOVINE (230 BLOOM)WIL1404U79IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT

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
meijer NIGHTTIME Sleep Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bede4cd-bf55-8b84-e063-6394a90aa5c92025-02-19WarningsExact identifier
ndc (package): 79481-0779-4
ndc (package): 79481-0779-8
ndc (product): 79481-0779
ndc11 (package): 79481077908
ndc11 (package): 79481077904
spl id: f47397e5-a047-4412-9299-b5d604b66852
spl set id: 1bede4cd-bf55-8b84-e063-6394a90aa5c9

Reported adverse events (FAERS/openFDA)#

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