Walgreens 44-480-childrens Allergy Relief

Walgreens 44-480-childrens Allergy Relief
SPL v5
SPL
SPL Set ID 0b34b5a3-98a2-4096-9d95-071bb5a63c86
Route
ORAL
Published
Effective Date 2025-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Dextrose Monohydrate Ethylcellulose, Unspecified Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Mannitol Stearic Acid Sucralose Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: 44;480 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-13

Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

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

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)
Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

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 0363-4810-09

Walgreens

  WALGREENS

PHARMACIST RECOMMENDED

Compare to the active ingredient in

Children’s Benadryl® Chewables††

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

Grape

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 44-480
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.

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

Active Ingredient (in Each Chewable Tablet)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

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

Purpose

Antihistamine

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)
Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Other Information (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 (Inactive ingredients)

dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

NDC 0363-4810-09

Walgreens

  WALGREENS

PHARMACIST RECOMMENDED

Compare to the active ingredient in

Children’s Benadryl® Chewables††

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

Grape

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 44-480
When Using This Product (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)