LEADER MAXIMUM STRENGTH SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

Leader Maximum Strength Sleep Aid by

Drug Labeling and Warnings

Leader Maximum Strength Sleep Aid 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 softgel)

Diphenhydramine HCl 50mg

Purpose

Nighttime sleep aid

Use

helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age

Do not use this product

with other products containing diphenhydramine, even one used on skin.

Ask a doctor or pharmacist before use if you have

emphysema

chronic bronchitis

glaucoma

difficulty in urination due to an enlargement of the prostate gland

When using this product

avoid alcoholic beverages.

Stop use and ask a doctor if

sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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 of age and over: take 1 softgel at bedtime if needed or as
directed by a doctor

Other information

• store at controlled room temperature 15°-30°C (59°-86°F)
• do not use if imprinted safety seal under cap is broken or missing
• *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®.

KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION

INACTIVE INGREDIENT

edible white ink, FDandC Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.

Questions or comments?

Call toll free: 1-800-200-6313

Distributed by:
Cardinal Health
Dublin, Ohio 43017

All Leader Brand Products are 100% satisfation guaranteed or return to place of purchase for a full refund

PRINCIPAL DISPLAY PANEL

*Compare to Maximum Strength Unisom® SleepGels®

NDC: 37205-0120-64

Maximum Strength Sleep Aid

Diphenhydramine HCl

Helps to reduce difficulty falling asleep

32 softgels

Container Label

Outer Carton Label

INGREDIENTS AND APPEARANCE

LEADER MAXIMUM STRENGTH SLEEP AID  
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-120
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	blue (BLUE)	Score	no score
Shape	OVAL (OVAL)	Size	13mm
Flavor		Imprint Code	P50;A99
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-120-64	1 in 1 BOX
1		32 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	06/05/2012

Labeler - Cardinal Health (097537435)