BERKLEY AND JENSEN SLEEP AID- doxylamine succinate tablet 
BJWC

----------

BJWC Sleep Aid Drug Facts

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

•
helps to reduce difficulty in falling asleep

Warnings

Do not use

in children under 12 years of age

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 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. (1-800-222-1222)

Directions

•
adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
•
children under 12 years of age: do not use

Other information

•
store at 68°-77°F (20°-25°C)
•
retain in carton until time of use
•
see carton end panel for lot number and expiration date

Inactive ingredients

anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-934-1204

Principal Display Panel

Compare to the active ingredient in Unisom® SleepTabs®

SLEEP AID

DOXYLAMINE SUCCINATE TABLETS, 25mg

NIGHTTIME SLEEP-AID

100% MONEY-BACK GUARANTEE

ACTUAL SIZE

GLUTEN FREE

192 TABLETS

ONE TABLET PER DOSE

2-96 COUNT BOTTLES

sleep-aid-image

BERKLEY AND JENSEN SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-441
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code L441
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68391-441-022 in 1 CARTON08/06/201807/31/2019
196 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016708/06/201807/31/2019
Labeler - BJWC (159082692)

Revised: 1/2021
Document Id: 3b219ae9-f9de-44ad-9a62-cdd7b97188a8
Set id: 25f468a9-71d4-40f2-97bb-1c3ff5d4b728
Version: 2
Effective Time: 20210115
 
BJWC