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Nighttime Sleep-Aid by Safeway, Inc.

Medically reviewed on May 1, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Safeway, Inc.
NDC Code: 21130-004

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

NIGHTTIME SLEEP-AID 
diphenhydramine hcl 25 mg capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize15mm
FlavorImprint CodeA41;602
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-004-2424 BLISTER PACK in 1 CARTON
11 CAPSULE in 1 BLISTER PACK
2NDC:21130-004-1212 BLISTER PACK in 1 CARTON
21 CAPSULE in 1 BLISTER PACK
3NDC:21130-004-4848 BLISTER PACK in 1 CARTON
31 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33812/31/2014
Labeler - Safeway, Inc. (009137209)

 
Safeway, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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