DIPHENHYDRAMINE HCL capsule

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each banded capsule)

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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.

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

Warnings

Do not use – to make a child sleepy – 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

This unit dose package is not child resistant and is intended for institutional use only. Keep out of the reach of children.

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away.

DO NOT USE IF BLISTER UNIT IS BROKEN

Directions-Take every 4 to 6 hours – do not take more than 6 doses in 24 hours

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

Inactive ingredients

D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Lactose and Starch

Storage

Store at 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature].

-protect from moisture

-contains lactose

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

MFGD By CPC, NY 11788

Distributed By:

Cardinal Health

Dublin, OH 43017

L36150280218

Principal Display Panel

Diphenhydramine HCl

Capsules 25 mg

10 Capsules

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-0683(NDC:0904-5306)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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, UNSPECIFIED FORM (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;835
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-0683-0	10 in 1 BAG	06/03/2011
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	06/03/2011

Labeler - Cardinal Health (603638201)