DIPHENHYDRAMINE HCL ORAL SOLUTION solution

Diphenhydramine HCl Oral Solution by

Drug Labeling and Warnings

Diphenhydramine HCl Oral Solution by is a Otc medication manufactured, distributed, or labeled by Kesin Pharma Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each 5 mL)

Diphenhydramine HCl, USP 12.5 mg

Purpose

Antihistamine

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

Warnings

Do not use

• with any other products 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

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

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.

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

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

SPL UNCLASSIFIED SECTION

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

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Revision 02/2025

PRINCIPAL DISPLAY PANEL

NDC: 81033-029-16

Diphenhydramine HCl

Oral Solution, USP

12.5 mg/5 mL

Antihistamine

Cherry Flavor

16 fl oz. (473 mL)

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL ORAL SOLUTION 
diphenhydramine hcl oral solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-029(NDC:84447-103)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HCL (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HCL	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POTASSIUM CITRATE (UNII: EE90ONI6FF)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-029-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/04/2025

Labeler - Kesin Pharma Corporation (117447816)