TOPCARE SLEEP AID- doxylamine succinate tablet

TopCare Sleep Aid by

Drug Labeling and Warnings

TopCare Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

1-888-423-0139

Principal Display Panel

COMPARE TO UNISOM® SLEEPTABS® ACTIVE INGREDIENT

NIGHTTIME

Sleep Aid

DOXYLAMINE SUCCINATE TABLETS, 25 mg

NIGHTTIME SLEEP-AID

OUR PHARMACITS RECOMMEND

Clinically Tested, Proven Effective

One Tablet Per Dose

32 TABLETS

actual size

INGREDIENTS AND APPEARANCE

TOPCARE SLEEP AID 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-441
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	25 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L441
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-441-64	32 in 1 CARTON	01/29/1997
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040167	01/29/1997

Labeler - Topco Associates LLC (006935977)