Drug Mart 44-728-Delisted

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Discount Drug Mart, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SLEEP AID- diphenhydramine hcl capsule, liquid filled 
Discount Drug Mart

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 Mart 44-728-Delisted

Active ingredient (in each liquid-filled capsule)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

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

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
  
• difficulty in urination due to enlargement of the 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

• do not take more than directed
  
• adults and children 12 years and over: take 1 capsule at bedtime if needed, or as directed by a doctor
• children under 12 years: do not use
  

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• protect from light, heat and moisture
  
• see end flap for expiration date and lot number
  

Inactive ingredients

FD&C blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

1-800-426-9391

Principal display panel

DISCOUNT
drug 
mart
FOOD FAIR

NDC: 53943-928-91

May Contain
Anti-Theft
Device

Sleep Aid

Diphenhydramine HCl 50 mg
Nighttime Sleep-Aid

*Compare to the active ingredient in Unisom® SleepGels®

Non-habit forming

Actual Size

64 Softgels

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

50844   ORG012072891

Product of Dubai
Packaged and Quality Assured in the USA

SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
STORE, SEND REASON FOR DISSATISFACTION, NAME,
ADDRESS AND EMPTY PACKAGE TO:
DISCOUNT DRUG MART
211 COMMERCE DRIVE, MEDINA, OHIO 44256

DISTRIBUTED BY: DRUG MART - FOOD FAIR
211 COMMERCE DRIVE, MEDINA, OH 44256
www.discount-drugmart.com

Drug Mart 44-728

SLEEP AID 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-928
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, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	blue (clear)	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	728
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53943-928-27	1 in 1 CARTON	11/11/2020	03/03/2023
1		32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 53943-928-91	1 in 1 CARTON	11/11/2020	03/03/2023
2		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	part338	11/11/2020	03/03/2023

Labeler - Discount Drug Mart (047741335)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(53943-928)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	pack(53943-928)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(53943-928)

Revised: 11/2022

Document Id: 3c9a2490-2369-44e3-b8fb-d8f9b04f827e

34390-5

Set id: 68b1cb16-037e-46f7-9c1f-8ff728031356

Version: 3

Effective Time: 20221119