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®

32ct Carton Label

32ct Bottle Label

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®

96ct Bottle Label Front

96ct Bottle Label Back

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/31/2013

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

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