Sleep Aid by TOP CARE (Topco Associates LLC) / P & L Development, LLC DRUG FACTS

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SLEEP AID MAXIMUM STRENGTH- diphenhydramine hcl capsule 
TOP CARE (Topco Associates LLC)

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

Use

• helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

with other products 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 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)

Inactive ingredients

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

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

MAXIMUM STRENGTH

Sleep Aid

NIGHTTIME LIQUIDCAPS (LIQUID FILLED SOFTGELS)

DIPHENHYDRAMINE HCl 50 mg

Helps To Reduce Difficulty Falling Asleep

COMPARE TO MAXIMUM STRENGTH UNISOM® SLEEPGELS® active ingredient*

SOFTGELS

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

topcare@topco.com

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Product Label

Top Care Sleep Aid Softgel

SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-230
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
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-230-64	1 in 1 BOX	05/31/2013	12/31/2019
1		64 in 1 BOTTLE, PLASTIC; 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	05/31/2013	12/31/2019

Labeler - TOP CARE (Topco Associates LLC) (006935977)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: 2fc4cbd1-2c30-4284-a2e3-92e5d02a8350

34390-5

Set id: c2bd328d-ddbb-41a5-adb3-29d85be55966

Version: 2

Effective Time: 20181227

 

TOP CARE (Topco Associates LLC)