DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML solution

DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML by

Drug Labeling and Warnings

DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML by is a Otc medication manufactured, distributed, or labeled by AARNA USA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

PURPOSE

Purpose

Antihistamine

WHEN USING

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

WARNINGS

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 & 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

OTHER SAFETY INFORMATION

Other Information
each 5 mL contains: sodium 8 mg
Store between 20°- 25°C (68°-77°F). Do not refrigerate
protect from light

INACTIVE INGREDIENT

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

QUESTIONS

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

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML 
diphenhydramine hcl 12.5 mg per 5 ml solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82568-0016
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82568-0016-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2025
2	NDC: 82568-0016-8	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2025
3	NDC: 82568-0016-6	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/14/2025

Labeler - AARNA USA INC. (118515992)