Unisom Sleeptabs

SPL v5

SPL

SPL Set ID f591d52f-5610-4517-a96f-1ed63deb00bc

Route

ORAL

Published

Effective Date 2026-01-14

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 Oxide Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: Unisom;ST Shape: oval Color: blue Size: 13 mm Score: 2

Marketing Status

ANDA Active Since 2016-01-15

Description

Unisom ® SleepTabs ® Doxylamine succinate tablets Nighttime Sleep-Aid Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Unisom ® SleepTabs ® Doxylamine succinate tablets Nighttime Sleep-Aid Drug Facts

Uses

helps to reduce difficulty in falling asleep

Section 42229-5

Unisom^® SleepTabs^®

Doxylamine succinate tablets Nighttime Sleep-Aid

Drug Facts

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 20º to 25ºC (68 º-77 ºF)
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: 1-8 66-844-2798 Monday- Friday 8am-6pm EST

Principal Display Panel

Unisom Sleeptabs

Doxylamine succinate

25 mg

Nighttime Sleep-Aid

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

sedative or any other sleep-aid
tranquilizers
any other antihistamines
any other drugs

Structured Label Content

Uses

helps to reduce difficulty in falling asleep

Section 42229-5 (42229-5)

Unisom^® SleepTabs^®

Doxylamine succinate tablets Nighttime Sleep-Aid

Drug Facts

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 20º to 25ºC (68 º-77 ºF)
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: 1-8 66-844-2798 Monday- Friday 8am-6pm EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Unisom Sleeptabs

Doxylamine succinate

25 mg

Nighttime Sleep-Aid

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)

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", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM OXIDE", "unii": "LMI26O6933", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps to reduce difficulty in falling asleep", "42229-5": "Unisom ® SleepTabs ® Doxylamine succinate tablets Nighttime Sleep-Aid Drug Facts", "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 20º to 25ºC (68 º-77 ºF) 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: 1-8 66-844-2798 Monday- Friday 8am-6pm EST", "PRINCIPAL DISPLAY PANEL": "Unisom Sleeptabs Doxylamine succinate 25 mg Nighttime Sleep-Aid 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": "sedative or any other sleep-aid tranquilizers any other antihistamines any other drugs"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:12.477063 · Updated: 2026-03-14T23:12:23.079612