FDA.reportPublic FDA data

ZZZQuil Nightime Sleep-Aid

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2024-04-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:05:50

Label at a glance#

ProductZZZQuil Nightime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each LiquiCap)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

• avoid alcoholic beverages

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 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

take only one dose per day (24 hours)

 adults & children 12 yrs & over 2 LiquiCaps at bedtime if needed or as directed by a doctor
 children under 12 yrs do not use

Other information

SPL UNCLASSIFIED SECTION

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-877-881-5813

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZzzquilZzzquil

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-156-012023-03-16C16284748780-1f386c64a-261b-0266-e053-dadaa90a7c1aZZZQuil Nightime Sleep-Aid
67751-156-012023-01-30C16284748780-1f386c64a-261b-0266-e053-dadaa90a7c1aZZZQuil Nightime Sleep-Aid

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-501-12EA - Each37000-5012c431dae-d36f-474d-9608-04ebde59634312017-06-15
37000-501-24EA - Each37000-501288b7430-60a0-4157-85bb-a5b2c6cc038012017-06-15
37000-501-48EA - Each37000-501a4ec1a0c-1100-4198-abcf-246fe803823d12017-06-15
37000-501-72EA - Each37000-501a8709c2e-1a82-47ca-9a7a-0272e149fa7b12017-06-15

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
67751-15667751-156-01
37000-501

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
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
16274f95-bed5-19f4-e063-6394a90a6835a8b12f40-38a4-4dad-b74b-d8c7604724fc2024-04-15WarningsExact identifier
spl id: 16274f95-bed5-19f4-e063-6394a90a6835
spl set id: a8b12f40-38a4-4dad-b74b-d8c7604724fc

Reported adverse events (FAERS/openFDA)#

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