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

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-367

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 44-367

Active ingredient
(in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

Warnings

Do not use
  • in 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
  • difficulty in urination due to enlargement of the prostate gland

  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • drowsiness will occur

  • use caution when driving a motor vehicle or operating machinery

  • 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

  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

  • children under 12 years: do not use

Other information
  • each caplet contains: calcium 30 mg

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

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

QUALITY
+ PLUS

NDC 50844-367-08

*Compare to active ingredient in Simply Sleep®

SLEEP AID
Diphenhydramine HCl 25 mg
NIGHTTIME SLEEP-AID

• Helps you Fall Asleep
• Does NOT Contain Pain Reliever

24 Caplets     Non-habit Forming      ACTUAL SIZE

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.

50844 ORG051636708

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-367

SLEEP AID 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-367
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;367
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-367-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/10/2000
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(50844-367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(50844-367), PACK(50844-367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(50844-367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-367)

 
L.N.K. International, Inc.

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Medically reviewed on Oct 31, 2018

Further information

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

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