DIPHENHYDRAMINE HCL capsule

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each banded capsule)

Diphenhydramine Hydrochloride 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

• 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

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, croscarmellose sodium, hard gelatin capsules, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline
cellulose, propyl paraben sodium.

Questions or comments?

Call toll-free 1-877-225-6999
Mfg Lic .No: TN/DRUGS/558/1997

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: 71399-8026
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

Product Characteristics
Color	pink (light pink)	Score	no score
Shape	capsule	Size	18mm
Flavor		Imprint Code	AP;26
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-8026-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2021
2	NDC: 71399-8026-2	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/15/2021

Labeler - Akron Pharma Inc. (067878881)