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ShopRite Sleep-Aid by Wakefern Food Corporation

Medically reviewed on August 23, 2017

Dosage form: tablet
Ingredients: DOXYLAMINE SUCCINATE 25mg
Labeler: Wakefern Food Corporation
NDC Code: 41190-441

ShopRite 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-SHOPRITE

Principal Display Panel

Compare to: Active Ingredient in Unisom® SleepTabs®

SLEEP-AID

Doxylamine Succinate Tablets, 25 mg

NIGHTTIME SLEEP-AID

One Tablet Per Dose

actual size

32 TABLETS

SHOPRITE SLEEP-AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-441
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint CodeL441
Contains    
Packaging
#Item CodePackage Description
1NDC:41190-441-6432 BLISTER PACK in 1 CARTON
11 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016705/16/2017
Labeler - Wakefern Food Corporation (069722418)

 
Wakefern Food Corporation

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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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