FDA.reportPublic FDA data

ZzzQuil

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-11-18
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:37:43

Label at a glance#

ProductZzzQuil
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 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 (2 LiquiCaps) 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

Storage and handling

store at no greater than 25°C (77°F) avoid excessive heat above 40°C (104°F) protect from light.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose (2 LiquiCaps) per day (24 hours)
adults & children 12 yrs & over2 LiquiCaps at bedtime if needed or as directed by a doctor
children under 12 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • store at no greater than 25°C (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, mannitol, polyethylene glycol, shellac*, sorbitan, sorbitol titanium dioxide*, water

*May contain these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

1-877-881-5813

SPL UNCLASSIFIED SECTION

Made in Canada

Dist. by Procter & Gamble, Cincinnati, OH 45202

Vicks® and LiquiCaps™ are trademarks of The Procter & Gamble Company
used with permission. All other products and brands are
the property of their respective owners.

Product repackaged and distributed with permission of manufacturer by:
Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404

1-877-507-6516 M-F (8 AM-4:30 PM CST) 97461C-US-04-22

PRINCIPAL DISPLAY PANEL - 2 LiquiCap Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coupon Inside! Save $1.00

on your next purchase of ONE ZzzQuil® product (excludes trial/travel size).

VICKS ®

ZzzQuil ™

NIGHTTIME SLEEP-AID
Diphenhydramine HCl

Not for colds or pain

Fall Asleep Fast

Non-Habit Forming

[LiquiCap image]


2

LiquiCaps™

[Lil' Drug Store ® logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN7
1248360ZzzQuil NIghttime Sleep Aid 25 MG Oral CapsulePSN7
1248360diphenhydramine hydrochloride 25 MG Oral Capsule [Zzzquil]SBD7
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD7
1248360Zzzquil 25 MG Oral CapsuleSY7

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
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
66715-9746-1ZzzQuil1 in 1 CARTONCAPSULE, LIQUID FILLED17
66715-9746-1ZzzQuil2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9746ZZZQUIL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIL' DRUG STORE PRODUCTS, INC.]7Current NDC, Legacy NDC, 2 package rows20241120_0b2777be-85d4-443d-b65f-6750e0ba97ba.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-974666715-9746-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
ZzzQuilDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.0b2777be-85d4-443d-b65f-6750e0ba97ba2024-11-18WarningsExact identifier
ndc (package): 66715-9746-1
ndc (product): 66715-9746
ndc11 (package): 66715974601
spl id: 2733bf33-a0be-9d8a-e063-6294a90a26ad
spl set id: 0b2777be-85d4-443d-b65f-6750e0ba97ba

Reported adverse events (FAERS/openFDA)#

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