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

Medically reviewed on January 9, 2018

Dosage form: tablet
Ingredients: DOXYLAMINE SUCCINATE 25mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-837

LNK 44-386

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have
  • glaucoma
  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking any other drugs.

When using this product
  • avoid alcoholic beverages
  • take only at bedtime 

Stop use and ask a doctor if

sleeplessness persists continuously for more than two 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: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • do not give to children under 12 years of age 

Other information
  • store at controlled room temperature 20º-25ºC (68º-77ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

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SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-837
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code44;386
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-837-223 BLISTER PACK in 1 CARTON
116 TABLET in 1 BLISTER PACK
2NDC:50844-837-272 BLISTER PACK in 1 CARTON
216 TABLET in 1 BLISTER PACK
3NDC:50844-837-191 BLISTER PACK in 1 CARTON
38 TABLET in 1 BLISTER PACK
4NDC:50844-837-712 BOTTLE in 1 CARTON
496 TABLET in 1 BOTTLE
5NDC:50844-837-461 BOTTLE in 1 CARTON
596 TABLET in 1 BOTTLE
6NDC:50844-837-8732 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACTANDA04056404/11/2002
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(50844-837)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(50844-837)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-837)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-837)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(50844-837)

 
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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