OTC Medication Information: Childrens Allergy Relief

CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride 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.

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 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

NDC 0363-4808-09

Walgreens

Compare to the active ingredient in
Children’s Benadryl® Chewables^††

WALGREENS PHARMACIST RECOMMENDED^†

Children’s
Allergy Relief

DIPHENHYDRAMINE HCl, 12.5 mg /
CHEWABLE TABLETS / ANTIHISTAMINE

Dye Free 4-6 Hour Dose

• Relieves itchy or runny nose,
sneezing, itchy throat &
itchy, watery eyes

AGES
6
YEARS &
OLDER

ACTUAL SIZE

Cherry
flavor

20 CHEWABLE
TABLETS

CHEW OR CRUSH TABLETS COMPLETELY BEFORE SWALLOWING.
DO NOT SWALLOW TABLETS WHOLE.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

^† Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.
^†† This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the
registered trademark Children’s
Benadryl® Chewables.

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com©2021 Walgreen Co.

50844 ORG121848009

Walgreens 44-481

CHILDRENS ALLERGY RELIEF diphenhydramine hcl tablet, chewable

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4808 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength DEXTROSE MONOHYDRATE ETHYLCELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE MANNITOL STEARIC ACID SUCRALOSE SUCROSE

Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor CHERRY Imprint Code 44;481 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0363-4808-09 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 5 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (0363-4808-09)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/13/2022

Labeler — Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	manufacture (0363-4808), pack (0363-4808)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		117025878	manufacture (0363-4808)

Revised: 05/2023 Walgreen Company