DIPHENHYDRAMINE HCL capsule

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals,Inc.. 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 temperature 15° to 30° C (59° to 86°F) 
• 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:
Akron Pharma, Inc,

373 RT US 46 W, Building E,

Suite 117, Fairfield, NJ 07004

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68071-3877(NDC:71399-1027)
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: 68071-3877-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/12/2025
2	NDC: 68071-3877-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	08/14/2025
3	NDC: 68071-3877-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2026

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

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	repack(68071-3877)