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

Medically reviewed on Feb 16, 2018

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-546

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.

Sound Body 44-654

Active ingredient (in each liquid-filled capsule)

Diphenhydramine HCl 25 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
  • 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
  • do not take more than directed
  • take only one dose per day (24 hours)
  • adults and children 12 years and over: take 2 capsules 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
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat above 40ºC (104ºF) and high humidity

Inactive ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

Sound Body™

*Compare to the active ingredient in VICKS® ZzzQuil™ NIGHTTIME SLEEP-AID LiquiCaps®

NDC 50844-546-08

Sleep-Aid

Diphenhydramine HCl 25 mg
NIGHTTIME SLEEP-AID

Non-habit Forming
Not for treating Cold or Flu

24 SOFTGELS

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 Procter & Gamble, owner of the registered trademark VICKS® ZzzQuil™ NIGHTTIME SLEEP-AID LiquiCaps®.

50844  ORG071665408

Product of China
Packaged and Quality Assured in the USA

Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788   USA
V#733000     ITEM#022765408

Sound Body 44-654



SLEEP AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-546
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize15mm
FlavorImprint Code654
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-546-082 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33802/28/2015
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(50844-546)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-546)

 
L.N.K. International, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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