SLEEP AID- doxylamine succinate tablet 
Wal-Mart Stores Inc

----------

Equate 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

  • glaucoma
  • a breathing problem such as asthma, 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 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?

1-888-287-1915

Principal display panel

equate™

NDC 49035-968-27

Compare to
Unisom®
SleepTabs®
active
ingredient*

Sleep-Aid
Doxylamine succinate 25 mg
Nighttime Sleep-Aid

• One Tablet Per Dose

Actual Size

32
TABLETS

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
PRODUCT OF ITALY

*This product is not manufactured or distributed by
Chattem, Inc., owner of the registered trademark
Unisom® SleepTabs®.          50844          REV0123B38627

Equate 44-386

Equate 44-386


SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-968
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:49035-968-2732 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056407/15/2019
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(49035-968)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(49035-968) , pack(49035-968)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(49035-968)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(49035-968)

Revised: 5/2024
Document Id: 5f9ffee6-72db-4fa2-b1ef-b691357815c4
Set id: 71e0cef1-6195-4b67-9c1f-b4e5fbeae53c
Version: 10
Effective Time: 20240510
 
Wal-Mart Stores Inc