SPL v3
SPL
SPL Set ID 32c26835-f54e-d7e5-e063-6294a90ae1c0
Route
ORAL
Published
Effective Date 2025-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Water Sodium Benzoate Sorbitol Solution Sodium Saccharin Sodium Citrate Anhydrous Citric Acid Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-14

Description

Active ingredient (in each 5 mL) Diphenhydramine HCl 12.5 mg


Medication Information

Warnings and Precautions

Warnings

Do not use

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

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.

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitabillty 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.

Indications and Usage

Directions

  • do not take more than 6 doses in any 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • 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

Description

Active ingredient (in each 5 mL) Diphenhydramine HCl 12.5 mg

Section 50567-7

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy of the nose or throat
Section 51727-6

Inactive Ingredients

anhydrous citric acid, bubble gum favor, purified water,sodium benzoate, sodium citrate, saccharin sodium, sorbitol solution, sucrose.

Section 51945-4

Section 53413-1

Questions or comments?

Please Call 1(877) 225-6999

Manufactured for:

AARNA USA INC

Leland, NC 28451

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Section 60561-8

Other Information

each 5 mL contains:
sodium 8 mg

Store between 20°- 25°C (68°-77°F). Do not refrigerate

protect from light


Structured Label Content

Indications and Usage (34067-9)

Directions

  • do not take more than 6 doses in any 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • 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

Warnings and Precautions (34071-1)

Warnings

Do not use

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

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.

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitabillty 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.

Section 50567-7 (50567-7)

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy of the nose or throat
Section 51727-6 (51727-6)

Inactive Ingredients

anhydrous citric acid, bubble gum favor, purified water,sodium benzoate, sodium citrate, saccharin sodium, sorbitol solution, sucrose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Please Call 1(877) 225-6999

Manufactured for:

AARNA USA INC

Leland, NC 28451

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Section 60561-8 (60561-8)

Other Information

each 5 mL contains:
sodium 8 mg

Store between 20°- 25°C (68°-77°F). Do not refrigerate

protect from light


Advanced Ingredient Data


Raw Label Data

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