LEADER SLEEP AID- doxylamine succinate tablet 
Cardinal Health 110, LLC. dba Leader

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Cardinal Health 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?

1-800-719-9260

Principal Display Panel

Sleep-Aid

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

One Tablet per Dose

COMPARE TO UNISOM® SLEEPTABS® active ingredient

48 TABLETS

Actual Size

100% Money Back Guarantee

Sleep-Aid Carton Image 1
Sleep-Aid Carton Image 2
LEADER SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0005
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:70000-0005-148 in 1 CARTON01/23/202002/28/2023
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016701/23/202002/28/2023
Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 6/2021
Document Id: 9ba1fc5a-d503-4e44-90f5-b6ac9606d6f6
Set id: 3e3ef662-9a31-4445-9006-55e009a1e3aa
Version: 3
Effective Time: 20210625
 
Cardinal Health 110, LLC. dba Leader