Big Lots, Inc Nighttime Sleep-aid Drug Facts

SPL v2

SPL

SPL Set ID da26764a-fa08-4b92-a7a5-fb20907f4555

Route

ORAL

Published

Effective Date 2020-07-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Doxylamine (25 mg)

Inactive Ingredients

Magnesium Stearate Microcrystalline Cellulose Anhydrous Dibasic Calcium Phosphate Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2019-04-24

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

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?

1-800-719-9260

Principal Display Panel

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

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

Clinically Tested, Proven Effective

32 TABLETS

One Tablet Per Dose

Actual Size

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)

Active Ingredient (in Each Tablet)

Doxylamine succinate 25 mg

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

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

Other Information (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 (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

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

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

Clinically Tested, Proven Effective

32 TABLETS

One Tablet Per Dose

Actual Size

When Using This Product (When using this product)

•
avoid alcoholic beverages
•
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 asthma, 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 any other drugs

Advanced Ingredient Data

[{"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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", "unii": "H3R47K3TBD", "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", "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?": "1-800-719-9260", "Principal Display Panel": "Compare to the active ingredient in Unisom ® SleepTabs ® Doxylamine Succinate Tablets, 25 mg Nighttime Sleep-Aid Clinically Tested, Proven Effective 32 TABLETS One Tablet Per Dose Actual Size", "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)", "Active ingredient (in each tablet)": "Doxylamine succinate 25 mg", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:24.903982 · Updated: 2026-03-14T22:57:55.937889