LEADER ALLERGY- diphenhydramine hcl capsule
Cardinal Health

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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Cardinal Health Allergy Capsules Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

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

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

Ask a doctor before use if you have

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

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. (1-800-222-1222)

Directions

•: take every 4 to 6 hours
•: do not take more than 6 doses in 24 hours

adults and children 12 years and over	1 to 2 capsules
children 6 to under 12 years	1 capsule
children under 6 years	do not use this product in children under 6 years of age

Inactive ingredients

anhydrous lactose, benzyl alcohol, butylparaben, D&C red no. 28, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate

Questions or comments?

1-800-719-9260

Principal Display Panel

Bonus Size

Compare to Benadryl® active ingredient

Allergy Capsules

Diphenhydramine HCl, 25 mg

Antihistamine

For Allergy Relief

Runny Nose – Sneezing

Itchy Throat – Itchy, Watery Eyes

Each capsule individually bonded for your protection

24 + 12 FREE = 36 CAPSULES

Actual Size

LEADER ALLERGY
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49781-134
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PROPIONATE (UNII: DK6Y9P42IN)

Product Characteristics
Color	PINK (clear) , WHITE (clear) , RED (band)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	L462
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49781-134-36	36 in 1 CARTON	01/02/2015	01/02/2015
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/02/2015	01/02/2015

Labeler - Cardinal Health (097537435)

Revised: 11/2017

Document Id: 96be49fa-308d-42f1-984a-ee45de883013

Set id: ebe348b8-0a03-4887-82ef-44b1f97f494c

Version: 2

Effective Time: 20171120

Cardinal Health