American Sales Company Nighttime Sleep Aid Drug Facts

SPL v4

SPL

SPL Set ID f8bfc874-53be-41e8-b59c-d538825761a8

Route

ORAL

Published

Effective Date 2025-04-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Doxylamine (25 mg)

Inactive Ingredients

Anhydrous Dibasic Calcium Phosphate Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance

Imprint: L441 Shape: oval Color: blue Size: 10 mm Score: 2

Marketing Status

ANDA Active Since 2016-05-06

Description

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

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, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

1-800-719-9260

Principal Display Panel

CAREone^®

Compare to the active ingredient in Unisom^® SleepTabs^®

NIGHTTIME SLEEP AID

Doxylamine Succinate Tablets, 25mg

Nighttime Sleep Aid

Clinically Tested, Proven Effective

One Tablet Per Dose

Gluten Free

Actual Size

32 TABLETS

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

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, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

CAREone^®

Compare to the active ingredient in Unisom^® SleepTabs^®

NIGHTTIME SLEEP AID

Doxylamine Succinate Tablets, 25mg

Nighttime Sleep Aid

Clinically Tested, Proven Effective

One Tablet Per Dose

Gluten Free

Actual Size

32 TABLETS

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

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": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "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, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "Questions or comments?": "1-800-719-9260", "Principal Display Panel": "CAREone ® Compare to the active ingredient in Unisom ® SleepTabs ® NIGHTTIME SLEEP AID Doxylamine Succinate Tablets, 25mg Nighttime Sleep Aid Clinically Tested, Proven Effective One Tablet Per Dose Gluten Free Actual Size 32 TABLETS", "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", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:51.444594 · Updated: 2026-03-14T23:08:14.770901