DIPHENDYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule
NCS HealthCare of KY, Inc 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.

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DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPSULE)

Diphenhydramine Hydrochloride 25 mg & 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

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Ask a doctor before use if you have

glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Ask a doctor or pharmacist before use if you are

taking taking tranquilizers or sedative.

When using this product

you may get drowsy; 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. Do not use any other products containing diphenhydramine.

If pregnant or breast-feeding,

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. (1-800-222-1222

DOSAGE & ADMINISTRATION

25mg:

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours.

Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.

Children under 6 years of age: ask a doctor

50mg:

Adults and children 12 years and over: take 50mg (1 capsule) 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

25mg: Store at controlled room temperature 59-86 degrees F.

50mg: Store at controlled room temperature 59-86 degrees F. Protect from excessive moisture.

INACTIVE INGREDIENTS

Lactose, starch, gelatin with bisulfites and artificial colors.

QUESTIONS OR COMMENTS?

Adverse drug event call: (800) 616-2471

PRINCIPAL DISPLAY PANEL

DIPHENDYDRAMINE HYDROCHLORIDE
diphendydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-7656(NDC:0904-5306)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
ANHYDROUS LACTOSE
STARCH, CORN
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	4mm
Flavor		Imprint Code	cpc;835
Contains

Packaging
#	Item Code	Package Description
1	NDC:0615-7656-39	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part348	01/02/2009

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	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE
GELATIN
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
MAGNESIUM STEARATE

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	4mm
Flavor		Imprint Code	cpc;836
Contains

Packaging
#	Item Code	Package Description
1	NDC:0615-7657-39	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part348	01/02/2009

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

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL, REPACK

Revised: 11/2011

Document Id: 87ec770b-5e0d-456f-87ee-e1b93c992047

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

Version: 2

Effective Time: 20111101

NCS HealthCare of KY, Inc dba Vangard Labs