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Nighttime Sleep Aid by Better Living Brands, LLC

Medically reviewed on Oct 2, 2017

Dosage form: tablet
Ingredients: DOXYLAMINE SUCCINATE 25mg
Labeler: Better Living Brands, LLC
NDC Code: 21130-386

Signature Care 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
  • 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

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.

SignatureCare 44-386


NIGHTTIME SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-386
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code44;386
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-386-272 BLISTER PACK in 1 CARTON
116 TABLET in 1 BLISTER PACK
2NDC:21130-386-223 BLISTER PACK in 1 CARTON
216 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/2002
Labeler - Better Living Brands, LLC (009137209)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(21130-386)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(21130-386)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(21130-386)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(21130-386)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(21130-386)

 
Better Living Brands, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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