Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 53e6f72d-15a4-4efe-8b1f-5753fed53df8
Route
ORAL
Published
Effective Date 2025-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Water Sodium Benzoate Trisodium Citrate Dihydrate Carboxymethylcellulose Sodium Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-03-31 Until 2027-03-31

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:

  • sneezing ​
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat
Directions
  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device. 
  • mL = milliliter
  • keep dosing cup with product 
  • find the right dose on the chart below
 age (yr)  dose (mL)
 children 6 to 11 years 5 mL to 10 mL
 children 2 to 5 years  do not use unless directed by a doctor
 children under 2 years do not use
Do Not Use
  •  with any other drug containing diphenhydramine, even one used on skin
  • to make a child sleepy
Package Label
WALGREENS Children's Allergy Relief Bubble Gum Flavor
Other Information
  • each 5 mL contains: sodium 8 mg
  • store between  20-25°C (68-77°F). Do not refrigerate.
  • Protect from light. Store in outer carton until contents are used.
Inactive Ingredients

anhydrous citric acid, carboxymethycellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Questions Or Comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Children's Benadryl® Allergy††

Children's

Allergy

DIPHENHYDRAMINE HCI 12.5 mg /

5 mL ANTIHISTAMINE

Dye Free 4-6 Hour Relief

Alcohol Free

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

AGES

6-11 YEARS

Bubble Gum

DOSAGE CUP PROVIDED

FL OZ (mL)

††This product is not manufactured or distributed by McNeil Consumer Healthcare distributors of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

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 (1-800-222-1222) 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
  • a sodium-restricted diet
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:

  • sneezing ​
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat
Purpose

Antihistamine

Directions
  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device. 
  • mL = milliliter
  • keep dosing cup with product 
  • find the right dose on the chart below
 age (yr)  dose (mL)
 children 6 to 11 years 5 mL to 10 mL
 children 2 to 5 years  do not use unless directed by a doctor
 children under 2 years do not use
Do Not Use (Do not use)
  •  with any other drug containing diphenhydramine, even one used on skin
  • to make a child sleepy
Package Label
WALGREENS Children's Allergy Relief Bubble Gum Flavor
Other Information (Other information)
  • each 5 mL contains: sodium 8 mg
  • store between  20-25°C (68-77°F). Do not refrigerate.
  • Protect from light. Store in outer carton until contents are used.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethycellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Questions Or Comments? (Questions or comments?)

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Children's Benadryl® Allergy††

Children's

Allergy

DIPHENHYDRAMINE HCI 12.5 mg /

5 mL ANTIHISTAMINE

Dye Free 4-6 Hour Relief

Alcohol Free

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

AGES

6-11 YEARS

Bubble Gum

DOSAGE CUP PROVIDED

FL OZ (mL)

††This product is not manufactured or distributed by McNeil Consumer Healthcare distributors of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

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 (1-800-222-1222) 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
  • a sodium-restricted diet
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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