NIGHTTIME 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

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 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

• Fall Asleep Fast
• One Tablet Per Dose 

25mg
32TABLETS

DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
50844    REV051338627

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49035-863
Route of Administration ORAL
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 OVAL 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 04/11/2002
1 32 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:49035-863-89 32 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2002
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: 4/2016
Document Id: a9c38b84-3a1b-4f74-ab23-a1c998f47417
Set id: 5b0bf558-31e9-4b95-b946-84d160a73572
Version: 5
Effective Time: 20160413
 
Wal-Mart Stores Inc