DIPHENHYDRAMINE HYDROCHLORIDE capsule

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active Ingredient

(in each banded capsule)

Diphenhydramine Hydrochloride 25mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing; itchy
• watery eyes
• itching of the nose or throat

Temporarily relieves these symptoms due to the common cold:

• runny nose
• sneezing

Warnings

Do not use

• to make child sleepy
• with any other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating 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
• 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

• 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 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

Other Information

• store at room temperature, USP

INACTIVE INGREDIENT

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

Questions or Comments?

(800) 231-4670

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Distributed By Cardinal Health

Dublin, Ohio 43017

www.myleader.com

Essential to Care™ since 1979

+This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. owner of the registered trademark Benadryl®

© 2016 Cardinal Health. All rights Reserved. Cardinal Health, the Cardinal Health Logo, Leadear and the Leader Logo are trademarks or registered trademarks of Cardinal Health. All other marks are property of their respective owners.

PRINCIPAL DISPLAY PANEL

NDC: 70000-0207-1

Allergy Capsules

Diphenhydramine HCL, 25 mg

Antihistamine

For Allergy Relief

Runny Nose, Itchy Throat, Sneezing and Itchy, Watery Eyes

24 Capsules

Compare to Benadryl® active ingredient+

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0207
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 (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink (Half pink and half clear with white powder inside)	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: 70000-0207-1	2 in 1 CARTON	01/31/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 70000-0207-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/13/2017

Labeler - Cardinal Health (097537435)