TOPCARE SLEEP AID- doxylamine succinate tablet 
Topco Associates LLC

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Topco Associates LLC. 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
with any other product containing doxylamine
unless you have time for a full night’s sleep

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking

a sedative or any other sleep-aid
tranquilizers
any other antihistamines
any other drugs

When using this product

avoid alcoholic beverages
do not drive a motor vehicle or operate machinery
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 20-25C (68-77F)
keep carton. It contains important information.

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?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO VICKS® ZZZQUIL® ULTRA ACTIVE INGREDIENT

NIGHTTIME

Sleep Aid

ULTRA

DOXYLAMINE SUCCINATE TABLETS, 25 mg

NIGHTTIME SLEEP-AID

Clinically Tested, Proven Effective

24 TABLETS

actual size

1 Tablet Dose

Sleep Aid Carton Image 1
Sleep Aid Carton Image 2
TOPCARE SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-159
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code L441
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-159-6224 in 1 CARTON06/16/2023
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:76162-159-6748 in 1 CARTON01/24/2024
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016706/16/2023
Labeler - Topco Associates LLC (006935977)

Revised: 3/2024
Document Id: d7fff893-f18b-4114-91fe-e9c1b1e3bbc6
Set id: d0295e0b-aba8-4cc7-b83c-b494d552413b
Version: 2
Effective Time: 20240328
 
Topco Associates LLC