DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
RedPharm Drug, 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.

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diph

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:

runny nose
sneezing
itchy, watery eyes
itchy throat and nose

Temporarily relieves these symptoms due to the common cold:

runny nose
sneezing

50 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold

sneezing
runny nose
itchy, watery eyes
itchy throat and nose

Do not use

25 MG

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

50 MG

to make a child sleepy
with any other product containing diphenhydramine, including one applied topically

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

50 MG

glaucoma
a breathing problem such as emphysema or chronic bronchitis
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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

diph

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1042(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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
STARCH, CORN (UNII: O8232NY3SJ)  
GELATIN (UNII: 2G86QN327L)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Colorpink (half pink and half clear with white powder inside, banded in red around the middle) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code cpc;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67296-1042-124 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/01/2018
Labeler - RedPharm Drug, Inc. (828374897)
Establishment
NameAddressID/FEIBusiness Operations
RedPharm Drug, Inc.828374897repack(67296-1042) , relabel(67296-1042)

Revised: 1/2018
Document Id: 6ab1c5d2-f7df-5a91-e053-2a91aa0a1fe3
Set id: 6ab1c5d2-f7de-5a91-e053-2a91aa0a1fe3
Version: 2
Effective Time: 20180101
 
RedPharm Drug, Inc.