SLEEP AID- doxylamine succinate tablet 
Kroger Company

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Kroger 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 emphysema or chronic bronchitis
  • 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?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient
of UNISOM® SLEEPTABS® *See back panel

NDC 30142-386-27

Kroger®

Nighttime Sleep-Aid

Sleep Aid
Doxylamine Succinate
Tablets, 25 mg
Nighttime Sleep-Aid

actual
size

One Tablet
Per Dose

32 TABLETS

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

*Unisom® and SleepTabs® are registered trademarks of
Chattem, Inc., Chattanooga, TN 37409. Chattem, Inc. is
not affiliated with The Kroger Co. or this product.

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
FOR MORE PRODUCT INFORMATION, SCAN UPC
USING YOUR KROGER APP OR CALL 800-632-6900

50844 REV0123B38627

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Kroger 44-386

Kroger 44-386

SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-386
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:30142-386-272 in 1 CARTON03/16/2021
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056403/16/2021
Labeler - Kroger Company (006999528)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(30142-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(30142-386) , pack(30142-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(30142-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(30142-386)

Revised: 8/2023
Document Id: 038e8ab0-6244-4533-8d57-828d6babe82f
Set id: 76e1e49d-eb57-4590-8cf8-91f29dbd15c3
Version: 4
Effective Time: 20230828
 
Kroger Company