FDA.reportPublic FDA data

Z-sleep

Manufacturer
Strategic Sourcing Services, LLC (Health Mart) | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd | LNK International, Inc.
Effective date
2020-03-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:38:21

Label at a glance#

ProductZ-sleep
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN protect from light see end flap for expiration date and lot number store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive heat above 40ºC (104ºF) and high humidity

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

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

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

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 a 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from light
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat above 40ºC (104ºF) and high humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Health Mart®

NDC 62011-0342-1

Compare to VICKS® ZzzQuil™
NIGHTTIME SLEEP-AID LiquiCaps®
active ingredient*

Z-Sleep
Diphenhydramine HCl 25 mg
Nighttime Sleep-Aid

Non-Habit Forming
Not For Treating Cold or Flu

Actual Size

12 Liquid Gels

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 Procter & Gamble, owner of the registered trademark VICKS® ZzzQuil™ NIGHTTIME SLEEP-AID LiquiCaps®.

50844   REV0716A65402

Product of China
Packaged and Quality Assured in the USA

McKESSON
Another Quality Product
Distributed by McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
healthmart.com

44-654
44-654

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0342-1EA - Each62011-03429e889855-921f-4114-b402-793473db57a012017-06-15

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62011-034262011-0342-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT

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
187b1b9d-5580-46ce-858f-a6b36e62227fc051510e-96c5-4e72-bf1b-efd14020779e2020-03-30WarningsExact identifier
spl id: 187b1b9d-5580-46ce-858f-a6b36e62227f
spl set id: c051510e-96c5-4e72-bf1b-efd14020779e

Reported adverse events (FAERS/openFDA)#

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