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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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Further information

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

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