Topco Associates Llc. Sleep Aid Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Doxylamine (25 mg)

Inactive Ingredients

Anhydrous Dibasic Calcium Phosphate Acacia Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 2 Aluminum Lake Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Sodium Starch Glycolate Type A Sucralose Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: 15N Shape: oval Color: purple Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2025-03-26

Medication Information

Purpose

Nighttime sleep-aid

Description

Doxylamine succinate 25 mg

Use

•
helps to reduce difficulty in falling asleep

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

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

Other Information

•
store at 20-25°C (68-77°F)
•
keep carton. It contains important information.

Inactive Ingredients

anhydrous dibasic calcium phosphate, arabic gum, artificial flavor, carmine, dibasic calcium phosphate dihydrate, FD&C blue no. 2 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, sucralose, talc, titanium dioxide, triacetin

Questions Or Comments?

1-888-423-0139

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).

Active Ingredient (in Each Tablet)

Doxylamine succinate 25 mg

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

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

BERRY FLAVOR

48 TABLETS

actual size

1 Tablet Dose

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

Structured Label Content

Use

•
helps to reduce difficulty in falling asleep

Purpose

Nighttime sleep-aid

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

Do Not Use (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

Other Information (Other information)

•
store at 20-25°C (68-77°F)
•
keep carton. It contains important information.

Inactive Ingredients (Inactive ingredients)

anhydrous dibasic calcium phosphate, arabic gum, artificial flavor, carmine, dibasic calcium phosphate dihydrate, FD&C blue no. 2 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, sucralose, talc, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

1-888-423-0139

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Doxylamine succinate 25 mg

Ask A Doctor Before Use If You Have (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

Package/label Principal Display Panel (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

BERRY FLAVOR

48 TABLETS

actual size

1 Tablet Dose

Ask A Doctor Or Pharmacist Before Use If You Are (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

Advanced Ingredient Data

[{"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2 ALUMINUM LAKE", "unii": "4AQJ3LG584", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "• helps to reduce difficulty in falling asleep", "Purpose": "Nighttime sleep-aid", "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", "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", "Other information": "• store at 20-25°C (68-77°F) • keep carton. It contains important information.", "Inactive ingredients": "anhydrous dibasic calcium phosphate, arabic gum, artificial flavor, carmine, dibasic calcium phosphate dihydrate, FD&C blue no. 2 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, sucralose, talc, titanium dioxide, triacetin", "Questions or comments?": "1-888-423-0139", "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).", "Active ingredient (in each tablet)": "Doxylamine succinate 25 mg", "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", "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 BERRY FLAVOR 48 TABLETS actual size 1 Tablet Dose", "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"}

Topco Associates Llc. Sleep Aid Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information