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NDC 00363-0599-44 Childrens Wal-Dryl Allergy 12.5 mg/1 Details

Childrens Wal-Dryl Allergy 12.5 mg/1

Childrens Wal-Dryl Allergy 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: 00363-0599-44
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	00363-0599
Product ID	0363-0599_4ab910e9-8b99-488c-8945-b5a6ae7a89e7
Associated GPIs	41200030107210
GCN Sequence Number	066974
GCN Sequence Number Description	diphenhydramine HCl TAB RAPDIS 12.5 MG ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	29414
HICL Sequence Number	004480
HICL Sequence Number Description	DIPHENHYDRAMINE HCL
Brand/Generic	Generic
Proprietary Name	Childrens Wal-Dryl Allergy
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	12.5
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	part341
Listing Certified Through	n/a

Package

Package Images

NDC 00363-0599-44 (00363059944)

Pricing Information	N/A
NDC Package Code	0363-0599-44
Billing NDC	00363059944
Package	3 BLISTER PACK in 1 CARTON (0363-0599-44) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2011-04-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 826c5868-c9bf-42b2-a97e-2e7ae6fae057 Details

Active ingredient (in each chewable tablet)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat

Warnings

Do not use

with any other product containing diphenhydramine, even one used on skin
to make a child sleepy

Ask a doctor before use if you have

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

taking sedatives or tranquilizers.

When using this product

marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
avoid alcoholic beverages
excitability may occur, especially in children

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

find right dose on chart below
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours

Age (yr)	Dose (chewable tablets)
children under 2 years	do not use
children 2 to 5 years	do not use unless directed by a doctor
children 6 to 11 years	1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over	2 to 4 chewable tablets (25 mg to 50 mg)

Other information

avoid high humidity
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to Children's Benadryl®

Chewables active ingredient††

NDC 0363-0599-44

children's

ALLERGY

Wal-Dryl®

DIPHENHYDRAMINE HCl, 12.5 mg /

ANTIHISTAMINE

CHEWABLE

4-6 HOUR DOSE

• Relieves itchy or runny nose,

sneezing, itchy throat &

itchy, watery eyes

18 CHEWABLE

TABLETS

6

YEARS

& OLDER

CHERRY

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

ǂWalgreens Pharmacist Survey

††This product is not manufactured or

distributed by Johnson & Johnson

Corporation, owner of the registered

trademark Children's Benadryl® Chewables.

50844 REV0317B59944

DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD.,

DEERFIELD, IL 60015

100% SATISFACTION

GUARANTEED

walgreens.com

©2018 Walgreen Co.

Walgreens 44-599

INGREDIENTS AND APPEARANCE

CHILDRENS WAL-DRYL ALLERGY

diphenhydramine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0599
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg

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

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	12mm
Flavor	CHERRY	Imprint Code	44;599
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0599-44	3 in 1 CARTON	04/25/2011	04/17/2023
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0363-0599-08	4 in 1 CARTON	04/25/2011	04/11/2014
2		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	part341	04/25/2011	04/17/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(0363-0599)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(0363-0599)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(0363-0599)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(0363-0599)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(0363-0599)

Revised: 6/2020

Document Id: 4ab910e9-8b99-488c-8945-b5a6ae7a89e7

Set id: 826c5868-c9bf-42b2-a97e-2e7ae6fae057

Version: 14

Effective Time: 20200606