CHILDRENS ALLERGY DYE-FREE WAL DRYL- diphenhydramine hcl tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Walgreen Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine - 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 - runny nose  - itchy, watery eyes - sneezing  - itching of the nose or throat
Authorization status:
OTC monograph final
Authorization number:
0363-0481-09

CHILDRENS ALLERGY DYE-FREE WAL DRYL- diphenhydramine hcl tablet, chewable

Walgreen Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Walgreens 44-481

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

chew or crush tablets completely before swallowing; do not swallow tablets whole

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

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

TORN OR BROKEN

see end flap for expiration date and lot number

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

avoid high humidity

Inactive ingredients

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 0363-0481-09

children’s

ALLERGY

Dye-Free

Wal-Dryl®

††

DIPHENHYDRAMINE HCl, 12.5 mg /

ANTIHISTAMINE

DYE FREE

CHEWABLE

4-6 HOUR DOSE

Relieves itchy or runny nose,

sneezing, itchy throat &

itchy, watery eyes

6 YEARS

& OLDER

ACTUAL SIZE

CHERRY FLAVOR

20 CHEWABLE

TABLETS

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

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens

100% SATISFACTION

GUARANTEED

walgreens.com ©2018 Walgreens Co.

†Walgreens Pharmacist Survey

This product is not manufactured or

distributed by Johnson & Johnson Corporation,

owner of the registered trademark Children’s

Benadryl® Chewables.

50844 REV1218A48109

PHARMACIST

RECOMMENDED

Walgreens

Trusted since 1901™.

Health expertise

you rely on.™

††

Walg reens 4 4 -4 81

CHILDRENS ALLERGY DYE-FREE WAL DRYL

diphenhydramine hcl tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 48 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

12.5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G)

ETHYLCELLULO SE, UNSPECIFIED (UNII: 7Z8 S9 VYZ4B)

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

Walgreen Company

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

12mm

Flavor

CHERRY

Imprint Code

44;48 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-0 48 1-0 9

4 in 1 CARTON

10 /10 /20 18

1

5 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

10 /10 /20 18

Labeler -

Walgreen Company (008965063)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(0 36 3-0 48 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

MANUFACTURE(0 36 3-0 48 1) , PACK(0 36 3-0 48 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(0 36 3-0 48 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(0 36 3-0 48 1)

Revised: 5/2020

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