DIPHENDYDRAMINE HYDROCHLORIDE- diphendydramine hydrochloride capsule
NCS HealthCare of KY, LLC dba Vangard Labs

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.

----------

Diphenhydramine Hydrochloride Capsules

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPSULE)

Diphenhydramine Hydrochloride 50 mg

PURPOSE

Antihistamine

USES

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.

WARNINGS

Do not use

• with any other products containing diphenhydramine including one applied topically

Ask a doctor before use if you have

• 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 taking tranquilizers or sedative.

When using this product

• marked drowsiness may occur

• avoid alcoholic drinks

• alcohol, sedatives and tranquilizers may increase drowsiness

• use caution 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

Adults and children 12 years and over: take 1 capsule (50mg) every 4 to 6 hours; not more than 6 capsules in 24 hours.

Children under 12 years: 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 25mg package.

OTHER INFORMATION

• store at controlled room temperature. USP

• do not use if either capsule band or imprinted safety seal under cap is broken or missing

• protect from excessive moisture

• use by expiration date on package

• contains lactose

INACTIVE INGREDIENTS

D&C red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose and starch.

QUESTIONS?

Adverse drug event call: (800) 616-2471

Distributed by:

Major® Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA M-29

R 12/09

PRINCIPAL DISPLAY PANEL

DIPHENDYDRAMINE HYDROCHLORIDE
diphendydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-7657(NDC:0904-5307)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
GELATIN (UNII: 2G86QN327L)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;836
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0615-7657-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/16/2011	06/30/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	01/02/2009	06/30/2017

Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)

Name	Address	ID/FEI	Business Operations
Establishment
NCS HealthCare of KY, LLC dba Vangard Labs		050052943	repack(0615-7657)

Revised: 11/2018

Document Id: ebb8ddde-654f-4348-9797-6acb4427be34

Set id: ac147fc9-d772-4d58-be39-aa1448e7dcd1

Version: 11

Effective Time: 20181115

NCS HealthCare of KY, LLC dba Vangard Labs