Diphenhydramine Hcl Oral Solution, Usp

Diphenhydramine Hcl Oral Solution, Usp
SPL v1
SPL
SPL Set ID 2f871005-de4d-8b2a-e063-6394a90aa43a
Route
ORAL
Published
Effective Date 2025-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Methylparaben Sucralose Propylene Glycol Propylparaben Anhydrous Citric Acid Sorbitol Ammonium Glycyrrhizate Potassium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-04
Description

Active Ingredients (in each 5 mL) Diphenhydramine HCl, USP 12.5 mg

Purpose

Antihistamine

Medication Information

Warnings and Precautions

Warnings

Purpose

Antihistamine

Description

Active Ingredients (in each 5 mL) Diphenhydramine HCl, USP 12.5 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
Section 42229-5

*This product is not manufactured by McNeil Consumer Healthcare, distributer of Benadryl Allergy.

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Revision 02/2025

Section 50565-1

Keep out of reach of children.

Section 50568-5

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

Section 51945-4

NDC 81033-029-16

Diphenhydramine HCl

Oral Solution, USP

12.5 mg/5 mL

Antihistamine

Cherry Flavor

16 fl oz. (473 mL)

Overdose

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Age (yr) Doses (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
  • with any other products containing diphenhydramine, even one used on skin
  • to make a child sleepy

Drug Facts

Active Ingredients (in each 5 mL)

Diphenhydramine HCl, USP 12.5 mg

Other Information
  • store at 20ºC to 25ºC (68ºF to 77ºF). Protect from light.
  • do not refrigerate
  • Do not use this product if printed inner seal is broken or missing.
Inactive Ingredients

cherry flavor, citric acid, methylparaben, monoammonium glcyrrhizinate, potassium citrate, propylene glycol, polyparaben, purified water, sorbitol, sucralose.

Questions Or Comments?

1-833-537-4679

When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
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
  • itching of the nose or throat
  • itchy, watery eyes
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

*This product is not manufactured by McNeil Consumer Healthcare, distributer of Benadryl Allergy.

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Revision 02/2025

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

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

Section 51945-4 (51945-4)

NDC 81033-029-16

Diphenhydramine HCl

Oral Solution, USP

12.5 mg/5 mL

Antihistamine

Cherry Flavor

16 fl oz. (473 mL)

Purpose

Antihistamine

Overdose

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Age (yr) Doses (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)
  • with any other products containing diphenhydramine, even one used on skin
  • to make a child sleepy

Drug Facts

Active Ingredients (in each 5 mL)

Diphenhydramine HCl, USP 12.5 mg

Other Information
  • store at 20ºC to 25ºC (68ºF to 77ºF). Protect from light.
  • do not refrigerate
  • Do not use this product if printed inner seal is broken or missing.
Inactive Ingredients (Inactive ingredients)

cherry flavor, citric acid, methylparaben, monoammonium glcyrrhizinate, potassium citrate, propylene glycol, polyparaben, purified water, sorbitol, sucralose.

Questions Or Comments? (Questions or comments?)

1-833-537-4679

When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
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: 2026-02-15T12:05:48.361528 · Updated: 2026-03-14T23:08:06.304944