Children's Benadryl ®

Children's Benadryl ®
SPL v10
SPL
SPL Set ID 10d478ff-ddc6-45da-87ff-cfe1b2b07a8e
Route
ORAL
Published
Effective Date 2021-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Glycerin Water Saccharin Sodium Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Solution

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-07-01
Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50568-5

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

Section 50570-1

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions
  • find right dose on chart below
  • mL = milliliter
  • 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

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information
  • each 5 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing
  • see bottom panel for lot number and expiration date
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions Or Comments?

call 1-877-717-2824 or 215-273-8755 (collect)

Principal Display Panel

NDC 50580-535-01

Children's

Benadryl ®

DYE-FREE ALLERGY

Diphenhydramine HCl/antihistamine

12.5 mg/5 mL oral solution

4-6 Hours/Dose

RELIEF OF:

  • Runny Nose
  • Sneezing
  • Itchy,Watery Eyes
  • Itchy Throat or Nose

✔ Free Of:

  • Dyes
  • Alcohol
  • Sugar
  • Parabens
  • High Fructose

    Corn Syrup

Bubble Gum!

Flavored Liquid

4 fl oz (118 mL)

When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
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

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

Section 50570-1 (50570-1)

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Purpose

Antihistamine

Directions
  • find right dose on chart below
  • mL = milliliter
  • 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

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information (Other information)
  • each 5 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions Or Comments? (Questions or comments?)

call 1-877-717-2824 or 215-273-8755 (collect)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-535-01

Children's

Benadryl ®

DYE-FREE ALLERGY

Diphenhydramine HCl/antihistamine

12.5 mg/5 mL oral solution

4-6 Hours/Dose

RELIEF OF:

  • Runny Nose
  • Sneezing
  • Itchy,Watery Eyes
  • Itchy Throat or Nose

✔ Free Of:

  • Dyes
  • Alcohol
  • Sugar
  • Parabens
  • High Fructose

    Corn Syrup

Bubble Gum!

Flavored Liquid

4 fl oz (118 mL)

When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:34.961735 · Updated: 2026-03-14T23:05:25.370894