NIGHTTIME SLEEP AID- doxylamine succinate tablet 
Wal-Mart Stores Inc

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Equate 44-386-Bisect-Delisted

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)
  • use by expiration date on package

Inactive ingredients

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

Questions or comments?

Call 1-888-287-1915

Principal display panel

NDC 49035-863-89

equate™

Compare to Unisom® SleepTabs® active Ingredient*

Sleep Aid
Doxylamine Succinate, 25 mg
Nighttime Sleep-Aid


One tablet per dose
• Easy to swallow

Actual Size
32 TABLETS

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    REV0513A38627

729665

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

Equate 44-386

Equate 44-386

NIGHTTIME SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-863
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;386
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-863-271 in 1 CARTON04/11/200205/05/2018
132 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:49035-863-8932 in 1 BOTTLE; Type 0: Not a Combination Product04/11/200208/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/200208/01/2022
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(49035-863)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(49035-863)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(49035-863)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(49035-863)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(49035-863)

Revised: 11/2019
Document Id: 92e2c9e3-169a-431f-9587-147852a96015
Set id: 5b0bf558-31e9-4b95-b946-84d160a73572
Version: 10
Effective Time: 20191113
 
Wal-Mart Stores Inc