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

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Signature Care 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

  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • glaucoma
  • 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

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at controlled room temperature 20º-25ºC (68º-77ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

dicalcium phosphate, 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

NDC 21130-386-27

Signature™
Care
Quality Guaranteed

COMPARE TO
Unisom® SleepTabs® active ingredient*

Nighttime
Sleep Aid
DOXYLAMINE SUCCINATE 25 mg
Nighttime Sleep-Aid
• Fall asleep fast/safe
• Easy to swallow
• 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     REV0513C38627

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

OUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK.

Signature Care 44-386

Signature Care 44-386


NIGHTTIME SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-386
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
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:21130-386-272 in 1 CARTON04/11/200208/01/2022
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:21130-386-223 in 1 CARTON04/11/200208/01/2022
216 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/200208/01/2022
Labeler - Better Living Brands, LLC (009137209)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(21130-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(21130-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(21130-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(21130-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(21130-386)

Revised: 10/2019
Document Id: 65ad496d-9473-4ad8-8005-20fc9e45e541
Set id: c7dea3ea-c9f5-4903-859b-3b7a3762f07e
Version: 8
Effective Time: 20191010
 
Better Living Brands, LLC