NIGHTTIME SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride 50 mg capsule, liquid filled

NIGHTTIME SLEEP AID Maximum Strength by

Drug Labeling and Warnings

NIGHTTIME SLEEP AID Maximum Strength by is a Otc medication manufactured, distributed, or labeled by EQUATE (Walmart Stores, Inc.), Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness

Warnings

Do not use

• for children under 12 years of age
• with any other product 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 an enlarged prostate gland

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

When using this product avoid alcoholic drinks

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of 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 (50 mg) at bedtime if needed, or as directed by adoctor

Other information

• store at 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

Call toll free 1-888-287-1915

PRINCIPAL DISPLAY PANEL - 32ct Carton and Bottle Label

Nighttime Sleep-Aid Maximum Strength

Diphenhydramine HCl, 50 mg 32 Softgels

Compare to Unisom® SleepGels® Active Ingredient*

NDC: 49035-237-16

Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716

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

PRINCIPAL DISPLAY PANEL - 96ct Bottle Label

Nighttime Sleep-Aid Maximum Strength

Diphenhydramine HCl, 50 mg 96 Softgels

Compare to Unisom® SleepGels® Active Ingredient*

NDC: 49035-237-96

Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716

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

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID MAXIMUM STRENGTH 
diphenhydramine hydrochloride 50 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-237
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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE (oblong)	Size	13mm
Flavor		Imprint Code	PC5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-237-16	1 in 1 CARTON	10/31/2013
1		32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 49035-237-96	96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/31/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/31/2013

Labeler - EQUATE (Walmart Stores, Inc.) (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd		421293287	MANUFACTURE(49035-237) , ANALYSIS(49035-237)