Sleep Aid by The Kroger Co. DRUG FACTS

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by The Kroger Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SLEEP AID- diphenhydramine hcl capsule 
The Kroger Co.

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.

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DRUG FACTS

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep- aid

Uses

• helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use

• With any other product containing diphenhydramine, even one used on skin.
  

Ask a doctor before use if you have

• emphysema
• chronic bronchitis
• glaucoma
• difficulty in urination due to an enlargement of the prostate gland

Ask doctor or pharmacist before use if you are now taking

sedatives or tranquilizers

When using this product

Avoid alcoholic beverages

Stop use and ask a doctor if

•  sleeplessness persists 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 accidental 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 at bedtime if needed or as directed by a doctor

Other information

• Store at controlled room temperature 15°-30°C (59°-86°F)
• do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

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

Questions or comments ?

call toll free 1-800-632-6900

Product Label

KROGER®

Sleep Aid

Diphenhydramine HCl, 50 mg

MAXIMUM STRENGTH

• Helps to reduce difficulty falling asleep

Compare to active ingredient in Maximum Strength Unisom Sleepgels® *See bottom panel

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Nighttime Sleep Aid

SLEEP AID 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-230
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	Size	13mm
Flavor		Imprint Code	P50;A99
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-230-32	1 in 1 CARTON	07/12/2010	12/31/2019
1		32 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 30142-230-64	1 in 1 CARTON	07/12/2010	12/31/2019
2		64 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/12/2010	12/31/2019

Labeler - The Kroger Co. (006999528)

Revised: 12/2018

Document Id: b6d077be-a8b1-41f9-8b6d-1135c4ef4bfa

34390-5

Set id: ddfe320a-6cfa-42bc-9375-b0fa375d972e

Version: 2

Effective Time: 20181214

 

The Kroger Co.