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Sleep Aid by L.N.K. International, Inc.

Medically reviewed on November 3, 2016

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-656

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.

Quality Plus 44-656

Active ingredient (in each liquid-filled capsule)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

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
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 (1-800-222-1222) right away.

Directions
  • adults and children12 years of age and over:
    1 capsule (50 mg) at bedtime if needed, or as directed by a doctor

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

‚Äč1-800-426-9391

Principal display panel

QUALITY PLUS                                           NDC 50844-656-27

                                               *Compare to active ingredient in Unisom® SleepGels®

SLEEP AID

Diphenhydramine HCl 50 mg
NIGHTTIME SLEEP-AID

Non-habit Forming

32
Liquid Gels                     One Liquid Gel Per Dose            ACTUAL SIZE

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    ORG031565627

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

Quality Plus 44-656

SLEEP AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-656
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50  mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
ColorBLUE (light) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code656
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-656-191 BLISTER PACK in 1 CARTON
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:50844-656-271 BOTTLE in 1 CARTON
232 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33803/01/2015
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(50844-656)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(50844-656)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(50844-656)

 
L.N.K. International, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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