Walgreens 44-799

Walgreens 44-799
SPL v3
SPL
SPL Set ID 7d972559-6184-476b-9cbf-1bc5663ea00d
Route
ORAL
Published
Effective Date 2025-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc

Identifiers & Packaging

Pill Appearance
Imprint: 44;799 Shape: oval Color: white Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-02

Description

Diphenhydramine HCl 50 mg

Purpose

Antihistamine 


Medication Information

Purpose

Antihistamine 

Description

Diphenhydramine HCl 50 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
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Directions
  • do not take more than directed
  • do not take more than 6 times in 24 hours
  • adults and children 12 years and over: take 1 caplet every 4 to 6 hours, or as directed by a doctor
  • children under 12 years: do not use
Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each caplet contains: calcium 50 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

Questions Or Comments?

1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday



Principal Display Panel

Walgreens

WALGREENS

PHARMACIST RECOMMENDED

Compare to the active ingredient in

Benadryl® Allergy Extra Strength††

EXTRA STRENGTH

Allergy Relief

DIPHENHYDRAMINE HCl CAPLETS, 50 mg / ANTIHISTAMINE

Dye-Free

Extra Strength

• Sneezing; itchy, watery eyes;

   runny nose & itchy throat

• Ages 12 years & older

24 CAPLETS

ACTUAL SIZE

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

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

NDC 0363-1799-08

Our pharmacists recommend the Walgreens brand.

  We invite you to compare to national brands.

††This product is not manufactured or distributed by Kenvue

    Inc., owner of the registered trademark Benadryl®.

50844      ORG022579908

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com


©2025 Walgreen Co.

Walgreens 44-799
When Using This Product
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
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.

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 50 mg

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.


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
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Purpose

Antihistamine 

Directions
  • do not take more than directed
  • do not take more than 6 times in 24 hours
  • adults and children 12 years and over: take 1 caplet every 4 to 6 hours, or as directed by a doctor
  • children under 12 years: do not use
Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each caplet contains: calcium 50 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

Questions Or Comments? (Questions or comments?)

1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday



Principal Display Panel

Walgreens

WALGREENS

PHARMACIST RECOMMENDED

Compare to the active ingredient in

Benadryl® Allergy Extra Strength††

EXTRA STRENGTH

Allergy Relief

DIPHENHYDRAMINE HCl CAPLETS, 50 mg / ANTIHISTAMINE

Dye-Free

Extra Strength

• Sneezing; itchy, watery eyes;

   runny nose & itchy throat

• Ages 12 years & older

24 CAPLETS

ACTUAL SIZE

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

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

NDC 0363-1799-08

Our pharmacists recommend the Walgreens brand.

  We invite you to compare to national brands.

††This product is not manufactured or distributed by Kenvue

    Inc., owner of the registered trademark Benadryl®.

50844      ORG022579908

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com


©2025 Walgreen Co.

Walgreens 44-799
When Using This Product (When using this product)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 50 mg

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

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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