DIPHENHYDRAMINE HCL capsule

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by AARNA USA INC., KJD PHARMA PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each banded capsule)

Diphenhydramine Hydrochloride 25 mg and 50 mg

Purpose

Antihistamine

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

Warnings

Do not use

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

Ask a doctor before use if you have

• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• marked drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• excitability may occur, especially in children
• be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

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.

Directions

• take every 4 to 6 hours 
• do not take more than 6 doses in 24 hours

25 mg Dosage:

• Age: Dose
• adults and children 12 years and over: 1 to 2 capsules
• children 6 to under 12 years of age: 1 capsule
• children under 6 years of age: do not use this product in children under 6 years of age

50 mg Dosage:

• Age: Dose
• adults and children 12 years and over: 1 capsules
• children under 12 years of age: ask a doctor, the proper dosage ; strength is not available in this ; package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the
25 mg. package.

Other information

• store at room temperature 20 º-25 ºC(68 º-77 ºF)
• do not use if either capsule band or imprinted safety seal under cap is broken or missing
• protect from moisture

Inactive ingredients

Colloidal silicon dioxide, Gelatin, Lactose Monohydrate, Magnesium Stearate, Microcrystalline cellulose

Questions or comments?

Call toll-free 1-877-225-6999

Manufactured for:

AARNA USA INC

Leland, NC 28451

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82568-0004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	pink (PINK WHITE)	Score	no score
Shape	CAPSULE (oblong)	Size	15mm
Flavor		Imprint Code	AD25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82568-0004-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2025
2	NDC: 82568-0004-2	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/06/2024

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82568-0005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	pink (PINK PINK)	Score	no score
Shape	CAPSULE (oblong)	Size	15mm
Flavor		Imprint Code	AD50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82568-0005-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2025
2	NDC: 82568-0005-2	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/30/2025

Labeler - AARNA USA INC. (118515992)

Establishment
Name	Address	ID/FEI	Business Operations
KJD PHARMA PRIVATE LIMITED		877256314	manufacture(82568-0004, 82568-0005)