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

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Equate 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

Other information

Inactive ingredients

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

Questions?

1-888-287-1915

Principal display panel

NDC 49035-863-27

equate®

Compare to Unisom® SleepTabs® Active Ingredient*

Doxylamine Succinate Tablets, 25 mg
Nighttime
Sleep Aid

Safe and Proven Effective

Fall Asleep Fast

Just One Tablet Per Dose 

25 mg
32 TABLETS

Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716 ©Wal-Mart Stores, Inc.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Unisom® SleepTabs®.
50844    REV0513B38627

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Equate 44-386

Equate 44-386

NIGHTTIME SLEEP AID 
doxylamine succinate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-863
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 25 mg
Inactive Ingredients
Ingredient Name Strength
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
Color BLUE Score 2 pieces
Shape CAPSULE Size 10mm
Flavor Imprint Code 44;386
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49035-863-27 1 in 1 CARTON
1 32 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040564 04/11/2002
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(49035-863)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(49035-863)

Revised: 3/2013
Document Id: bd41fe6d-7ae6-4346-99b9-490944968d97
Set id: 5b0bf558-31e9-4b95-b946-84d160a73572
Version: 3
Effective Time: 20130307
 
Wal-Mart Stores Inc