NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Safeway, Inc., P & L Development, LLC. 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

• with any other product containing diphenhydramine, even one used on skin
• 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
• heart disease
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep-aid.

When using this product

• drowsiness will occur
• avoid alcoholic beverages and other drugs that cause drowsiness
• be careful when driving a motor vehicle or operating machinery

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.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take only one dose per day (24 hours) - see Overdose warning
• swallow whole; do not crush, chew, or dissolve
• adults & children 12 yrs & over
  • one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F) and high humidity
• protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

Questions or comments?

Call 1-888-SAFEWAY Monday-Friday 7AM-6PM PST

Principal Display Panel

Compare to ZzzQuil® active ingredient*

Nighttime Sleep-Aid

Diphenhydramine HCl 25 mg

Nighttime Sleep-Aid

Non Habit-Forming

Not for Treating Cold or Flu

See Warnings

SOFTGELS (LIQUID FILLED CAPSULES)

DISTRIBUTED BY SAFEWAY INC.

P.O. BOX 99

PLEASANTON, CA 94566-0009

www.safeway.com

PRODUCT OF CANADA

*This product is not manufactured or distributed by The Procter & Gamble Company, VICKS®, LIQUICAPS®, and ZZZQUIL® are registered trademarks of The Procter & Gamble Company.

Failure to follow these warnings could result in serious consequences.

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.

Product Label

Safeway Nighttime Sleep Aid Softgel

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-225
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)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITAN (UNII: 6O92ICV9RU)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-225-24	2 in 1 CARTON	05/31/2013	12/31/2020
1		12 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	05/31/2013	12/31/2020

Labeler - Safeway, Inc. (009137209)

Registrant - P & L Development, LLC (800014821)