SLEEP-AID MAXIMUM STRENGTH- diphenhydramine hcl capsule

Sleep-Aid by

Drug Labeling and Warnings

Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by ASSURED / DOLLAR TREE (Greenbrier International, Inc.), P and L Development of New York Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

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 before use if you have

• emphysema
• chronic bronchitis
• glaucoma
• difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are now taking

sedatives or tranquilizers.

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)

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special

Principal Display Panel

*Compare to the active ingredient in Maximum Strength Unisom® SleepGels®

Maximum Strength Sleep-Aid

Diphenhydramine HCl

Helps to reduce difficulty falling asleep

50 mg EACH

SOFTGELS

Distributed by:

Greenbrier International, Inc.

Chesapeake, VA 23320

THIS PRODUCT IS SEALED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®.

Product Label

Assured Maximum Strength Sleep-Aid

INGREDIENTS AND APPEARANCE

SLEEP-AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-2300
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)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	P50;A99
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-2300-8	1 in 1 CARTON
1		8 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/06/2010

Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)

Registrant - P and L Development of New York Corporation (800014821)