DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule 
Akron Pharma Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Akron Pharma, Inc.

Active ingredient (in each banded capsule)

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Uses

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

AgeDose
adults and children 12 years and over1 to 2 capsules
children 6 to under 12 years of age1 capsule
children under 6 years of agedo not use this product in children under 6 years of age

Other information

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

50mg

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8026
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (light pink) Scoreno score
ShapecapsuleSize18mm
FlavorImprint Code AP;26
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-8026-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2021
2NDC:71399-8026-21000 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/15/2021
Labeler - Akron Pharma Inc. (067878881)

Revised: 2/2023
Document Id: d89d316b-1d9b-451d-9502-a90a92e5b9bb
Set id: aa8e72b9-ae59-4563-b3c7-9d48d0cc2c52
Version: 5
Effective Time: 20230226
 
Akron Pharma Inc.