NIGHTTIME SLEEP-AID- diphenhydramine hcl 25 mg capsule

Nighttime Sleep-Aid by

Drug Labeling and Warnings

Nighttime Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by Safeway, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

 Diphenhydramine HCl 25 mg

Purpose

 Nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

• for children under 12 years of age
• with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

Ask a doctor before use if you have

• a breathing problem such as asthma, 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 beverages

Stop use and ask a doctor if

 sleeplessness persists continuously 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

• take only one dose (2 softgels) per day (24 hours) 
• swallow whole; do not crush, chew, or dissolve
• adults and children 12 years and over: take 2 softgels at bedtime, if needed, or as directed by a doctor
• children under 12 years of age: do not use

Other information

•  store between 20-25ºC (68-77ºF)
• avoid excessive heat above 40ºC (104ºF) and high humidity
• protect from light

Inactive ingredients

 edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol*, purified water, sorbitan, sorbitol

*may contain this ingredient

Questions or comments?

 Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

COMPARE TO ZZZQUIL® active ingredient†

Nighttime Sleep-Aid

DIPHENHYDRAMINE HCl 25 mg

• Non-habit forming
• Not for treating cold or flu

SOFTGELS

Failure to follow these warnings could result in serious consequences

†This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

Product of India

Package Label

SIGNATURE CARE Nighttime Sleep Aid

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP-AID 
diphenhydramine hcl 25 mg capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-004
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	A41;602
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-004-24	24 in 1 CARTON	12/31/2014
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 21130-004-12	12 in 1 CARTON	12/31/2014
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 21130-004-48	48 in 1 CARTON	12/31/2014
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	12/31/2014

Labeler - Safeway, Inc. (009137209)