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NDC 00363-6850-08 Wal Sleep Z 25 mg/1 Details

Wal Sleep Z 25 mg/1

Wal Sleep Z is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 00363-6850-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	00363-6850
Product ID	0363-6850_ee893e15-25be-4d3c-a4ee-b66b4e82be65
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Wal Sleep Z
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Walgreen Company
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part338
Listing Certified Through	n/a

Package

Package Images

NDC 00363-6850-08 (00363685008)

Pricing Information	N/A
NDC Package Code	0363-6850-08
Billing NDC	00363685008
Package	4 BLISTER PACK in 1 CARTON (0363-6850-08) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2019-02-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f8512422-56b1-4e85-b605-c02ff34af706 Details

Active ingredient (in each chewable tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

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

Warnings

Do not use

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

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

taking sedatives or tranquilizers.

When using this product

avoid alcoholic beverages.

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

do not take more than directed
chew or crush tablets completely before swallowing; do not swallow tablets whole
take only one dose per day (24 hours)
adults and children 12 years and over: 2 chewable tablets at bedtime if needed, or as directed by a doctor
children under 12 years: do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
avoid high humidity
see end flap for expiration date and lot number

Inactive ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

1-800-426-9391

Principal display panel

Walgreens

Compare to the active ingredient in

VICKS® ZzzQuilTM††

NDC 0363-6850-08

Wal-Sleep Z®

DIPHENHYDRAMINE HCl, 25 mg / CHEWABLE TABLETS

NIGHTTIME SLEEP-AID CHEWABLE

• Non-habit forming

• Not for treating Cold or Flu

Chew or crush tablets completely before swallowing.

Do not swallow tablets whole.

24 CHEWABLE

TABLETS

GRAPE

FLAVOR

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

†Walgreens Pharmacist Survey

††This product is not manufactured or

distributed by Procter & Gamble, owner of

the registered trademark VICKS® ZzzQuil™.

50844 REV0119A68508

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2018 Walgreen Co.

Walgreens 44-685

INGREDIENTS AND APPEARANCE

WAL SLEEP Z

diphenhydramine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-6850
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	purple	Score	no score
Shape	ROUND	Size	13mm
Flavor	GRAPE	Imprint Code	44;685
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-6850-08	4 in 1 CARTON	02/07/2019	11/03/2023
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	02/07/2019	11/03/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0363-6850)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-6850)

Revised: 4/2022

Document Id: ee893e15-25be-4d3c-a4ee-b66b4e82be65

Set id: f8512422-56b1-4e85-b605-c02ff34af706

Version: 5

Effective Time: 20220413