db5a5eff-1bb1-4d00-8c01-caae7a1c7223

SPL v5
SPL
SPL Set ID db5a5eff-1bb1-4d00-8c01-caae7a1c7223
Route
oral
Published
Effective Date 2025-12-09
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 potassium citrate water sodium benzoate sorbitol sucralose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2022-07-22

Purpose

Antihistamine

Description

Diphenhydramine HCl USP 12.5 mg


Medication Information

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
  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • mL = milliliter

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 designed for use with this product. Do not use any other dosing device.

Other Information
  • each 5 mL contains: sodium 3 mg
  • store at room temperature
  • protect from sunlight
  • see bottom panel for lot number and expiration date
  • contains low sodium
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Description

Diphenhydramine HCl USP 12.5 mg

Principal Display Panel

NDC 51316-710-08

*Compare to theactive ingredient in Children's Benadryl® Dye-Free*

Dye-Free

Children’s Allergy Relief

Diphenhydramine HCl l Antihistamine

Oral Solution

For Relief Of:

  • Runny nose
  • sneezing
  • itchy, watery eyes
  • Itchy Throat or Nose

Sugar Free

Natural Cherry Flavor

8 FL. OZ. (236 mL)

Distributed by:

*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.

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 50567-7

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Section 50568-5

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

Section 50569-3

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
Section 50570-1

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

1-866-467-2748

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl USP 12.5 mg


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
  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • mL = milliliter

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 designed for use with this product. Do not use any other dosing device.

Other Information (Other information)
  • each 5 mL contains: sodium 3 mg
  • store at room temperature
  • protect from sunlight
  • see bottom panel for lot number and expiration date
  • contains low sodium
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 51316-710-08

*Compare to theactive ingredient in Children's Benadryl® Dye-Free*

Dye-Free

Children’s Allergy Relief

Diphenhydramine HCl l Antihistamine

Oral Solution

For Relief Of:

  • Runny nose
  • sneezing
  • itchy, watery eyes
  • Itchy Throat or Nose

Sugar Free

Natural Cherry Flavor

8 FL. OZ. (236 mL)

Distributed by:

*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.

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 50567-7 (50567-7)

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
Section 50570-1 (50570-1)

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

1-866-467-2748

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl USP 12.5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)