NIGHTTIME SLEEP AID- doxylamine succinate tablet 
Better Living Brands, LLC

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Signature Care 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

  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

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?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

Signature
care®

Quality Guaranteed

COMPARE TO
Unisom®
SleepTabs®
active ingredient*

NDC 21130-986-27

Nighttime
Sleep Aid

DOXYLAMINE SUCCINATE TABLETS,
25 mg
Nighttime Sleep-Aid

• One tablet per dose

Actual Size

32 TABLETS

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

*This product is not manufactured or distributed by
Chattem, Inc., distributors of Unisom® SleepTabs®.
50844       REV0123F38627

DISTRIBUTED BY: BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
‡1-888-723-3929

LOVE IT

OR IT’S ON US

Signature Care 44-386

Signature Care 44-386

NIGHTTIME SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-986
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:21130-986-272 in 1 CARTON07/15/2019
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056407/15/2019
Labeler - Better Living Brands, LLC (009137209)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(21130-986)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(21130-986) , pack(21130-986)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(21130-986)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(21130-986)

Revised: 7/2023
Document Id: 55826382-855d-433f-bf24-aaf1c8418340
Set id: 92827089-88d5-4f4e-bcbe-3ca6d94ee96c
Version: 6
Effective Time: 20230728
 
Better Living Brands, LLC