SLEEP AID- diphenhydramine hcl capsule, liquid filled 
L.N.K. International, Inc.

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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Quality Plus 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
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

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

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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

QUALITY
+PLUS

NDC 50844-228-19

*Compare to active ingredient in
Unisom® SleepGels®

SLEEP AID
Diphenhydramine HCl 50 mg
NIGHTTIME SLEEP-AID

Safe, Effective & Non-habit Forming
Helps You Fall Asleep

8
Liquid Gels

One Liquid Gel
Per Dose

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT
IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by
Chattem, Inc., owner of the registered trademark
Unisom® SleepGels®.     50844     ORG012072819

Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
Product of Dubai
Packaged and Quality Assured in the USA

Quality Plus 44-728

Quality Plus 44-728

SLEEP AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-228
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50  mg
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScoreno score
ShapeOVALSize14mm
FlavorImprint Code 728
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-228-191 in 1 CARTON11/19/202011/11/2023
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50844-228-274 in 1 CARTON11/19/202011/11/2023
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50844-228-13250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/202011/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33811/19/202011/11/2023
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(50844-228)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(50844-228)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(50844-228)

Revised: 6/2023
Document Id: 666dc3b5-fe07-4ec9-8982-741c2c3c56da
Set id: 9fdffc08-a514-4cfb-b58d-122ef0383852
Version: 5
Effective Time: 20230626
 
L.N.K. International, Inc.