Walgreens 44-018

Walgreens 44-018
SPL v5
SPL
SPL Set ID e49d2a0f-6588-439b-8a46-c073e0bc4f9a
Route
ORAL
Published
Effective Date 2025-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-18

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
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
Directions
  • do not take more than directed
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr) Dose (mL)
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 5 mL to 10 mL
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each 5 mL contains: sodium 4 mg
  • 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

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 0363-8018-36

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Compare to the active ingredient in

Children’s Benadryl® Dye-Free Allergy††

Children’s

Allergy

Relief

DIPHENHYDRAMINE HCl

12.5 mg PER 5 mL

ORAL SOLUTION

ANTIHISTAMINE

Dye Free

4–6 Hour Relief

• Relieves itchy or runny nose,

  sneezing, itchy throat

  & itchy, watery eyes

• Sugar free

AGES

6-11

YEARS

4 FL OZ (118 mL)

Bubble Gum

flavor

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DOSAGE CUP PROVIDED

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®

Dye-Free Allergy.      50844  ORG012301836

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

Walgreens

100% SATISFACTION

GUARANTEED

walgreens.com

©2023 Walgreen Co.

Walgreens 44-018
When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in 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 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has
  • a breathing problem such as chronic bronchitis
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers.


Structured Label Content

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

Antihistamine

Directions
  • do not take more than directed
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr) Dose (mL)
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 5 mL to 10 mL
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each 5 mL contains: sodium 4 mg
  • 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)

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

NDC 0363-8018-36

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Compare to the active ingredient in

Children’s Benadryl® Dye-Free Allergy††

Children’s

Allergy

Relief

DIPHENHYDRAMINE HCl

12.5 mg PER 5 mL

ORAL SOLUTION

ANTIHISTAMINE

Dye Free

4–6 Hour Relief

• Relieves itchy or runny nose,

  sneezing, itchy throat

  & itchy, watery eyes

• Sugar free

AGES

6-11

YEARS

4 FL OZ (118 mL)

Bubble Gum

flavor

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DOSAGE CUP PROVIDED

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®

Dye-Free Allergy.      50844  ORG012301836

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

Walgreens

100% SATISFACTION

GUARANTEED

walgreens.com

©2023 Walgreen Co.

Walgreens 44-018
When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
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 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • a breathing problem such as chronic bronchitis
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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