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Topcare Sleep Aid Prescribing Information

Package insert / product label
Generic name: doxylamine succinate
Dosage form: tablet
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics

Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Indications and Usage for Topcare Sleep Aid

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)

Topcare Sleep Aid Dosage and Administration

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

Storage and Handling

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?

1-888-423-0139

Principal Display Panel

TopCare® health

COMPARE TO UNISOM® SLEEPTABS® ACTIVE INGREDIENT

NIGHTTIME

Sleep Aid

DOXYLAMINE SUCCINATE TABLETS, 25 mg

NIGHTTIME SLEEP-AID

• Clinically Tested, Proven Effective

• One Tablet Per Dose

32 TABLETS

actual size

441-88-sleep-aid
TOPCARE SLEEP AID
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-441
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
ColorBLUEScoreno score
ShapeOVALSize10mm
FlavorImprint CodeL441
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-441-6432 in 1 CARTON01/29/1997
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016701/29/1997
Labeler - Topco Associates LLC (006935977)

Frequently asked questions

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