DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Preferred Pharmaceuticals, Inc.

----------

0835&0836(box unit)-Major

Active Ingredient (in each banded capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

25 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
o
runny nose
o
sneezing
o
itchy, watery eyes
o
itchy throat and nose
Temporarily relieves these symptoms due to the common cold:
o
runny nose
o
sneezing

50 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
o
sneezing
o
runny nose
o
itchy, watery eyes
o
itchy throat and nose

WARNINGS

Do not use

25 MG

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

Ask a doctor before use if you have

25 MG

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

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers

When using this product

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

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 right away.

Directions

Take every 4-6 hours
Do not take more than 6 doses in 24 hours

25 MG

adults and children 12 years of age and over

1 to 2 capsules

children 6 years 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

adults and children 12 years of age and over

1 capsule

children 6 years to 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 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
Protect from moisture
Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,
-
Livonia, MI 48152

Repackaged by Preferred Pharmaceuticals, Inc.

NDC 68788-7589

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine HCl Capsules 25mg
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7589(NDC:0904-5306)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorpink (half pink and half clear with white powder inside) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7589-110 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2019
2NDC:68788-7589-515 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2019
3NDC:68788-7589-330 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug34101/02/2009
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022REPACK(68788-7589)

Revised: 4/2024
Document Id: 8b4b1b34-a68c-4df4-b850-56a86498e246
Set id: 93b7852e-b9d5-4754-a5a3-b157ed19b4d3
Version: 7
Effective Time: 20240410
 
Preferred Pharmaceuticals, Inc.