NIGHTTIME SLEEP AID- doxylamine succinate tablet 
L.N.K. International, Inc.

----------

Quality Plus 44-386

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

Warnings

Do not use

  • in children under 12 years of age
  • with any other product containing doxylamine
  • unless you have time for a full night’s sleep

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking

  • sedatives or any other sleep-aid
  • tranquilizers
  • any other antihistamines
  • any other drugs

When using this product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • 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 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 right away.

Directions

Other information

Inactive ingredients

dibasic calcium phosphate dihydrate, 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

Principal display panel

QUALITY
+PLUS

NDC 50844-386-19

*Compare to active ingredient in
Unisom® SleepTabs®

NIGHTTIME
SLEEP AID

Doxylamine succinate tablets, 25 mg

Nighttime Sleep-Aid

One Tablet Per Dose

8
Tablets

ACTUAL SIZE

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 Chattem,
Inc., owner of the registered trademark Unisom® SleepTabs®.
50844          REV0123B38619

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

Quality Plus 44-386

Quality Plus 44-386

NIGHTTIME SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-386
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize10mm
FlavorImprint Code 44;386
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-386-191 in 1 CARTON04/11/2002
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50844-386-9032 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/2002
3NDC:50844-386-272 in 1 CARTON04/11/2002
316 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:50844-386-223 in 1 CARTON04/11/2002
416 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:50844-386-962 in 1 CARTON04/11/2002
596 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/2002
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(50844-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(50844-386) , pack(50844-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(50844-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(50844-386)

Revised: 3/2024
Document Id: 752c0fe1-456d-4af4-8db7-16cf86ce2704
Set id: 918ad808-ccfd-429f-9052-19905a634606
Version: 8
Effective Time: 20240325
 
L.N.K. International, Inc.