Principal Display Panel

SPL v8

SPL

SPL Set ID ccbc928b-f783-4337-b5be-83e241fc10ac

Route

ORAL

Published

Effective Date 2025-04-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging

Description

Doxylamine succinate 25 mg

Medication Information

Indications and Usage

helps to reduce difficulty in falling asleep

Dosage and Administration

adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years: do not use

Description

Doxylamine succinate 25 mg

Section 44425-7

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number

Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.

Section 50567-7

avoid alcoholic beverages take only at bedtime

Section 50568-5

taking any other drugs.

Section 50569-3

a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma

Section 50570-1

in children under 12 years of age

Section 51727-6

dibasic calcium phosphate dihydrate, FD & C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Section 51945-4

sunmark ® *COMPARE TO UNISOM ® SLEEPTABS ® ACTIVE INGREDIENT NDC 70677-0068-1 sleep aid DOXYLAMINE SUCCINATE 25 mg Nighttime Sleep-Aid One tablet per dose 32 TABLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®. 50844 REV1120B38627 Distributed by McKesson Corp., via Strategic Sourcing Services, LLC Memphis, TN38141 © 2003 McKesson Corporation www.sunmarkbrand.com Money Back Guarantee Sunmark 44-386

Section 53413-1

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Section 53414-9

ask a health professional before use.

Section 55105-1

Nighttime sleep-aid

Section 55106-9

Doxylamine succinate 25 mg

Structured Label Content

Indications and Usage (34067-9)

helps to reduce difficulty in falling asleep

Dosage and Administration (34068-7)

adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years: do not use

Section 44425-7 (44425-7)

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.

Section 50567-7 (50567-7)

avoid alcoholic beverages take only at bedtime

Section 50568-5 (50568-5)

taking any other drugs.

Section 50569-3 (50569-3)

a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma

Section 50570-1 (50570-1)

in children under 12 years of age

Section 51727-6 (51727-6)

dibasic calcium phosphate dihydrate, FD & C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Nighttime sleep-aid

Section 55106-9 (55106-9)

Doxylamine succinate 25 mg

Raw Label Data

All Sections (JSON)

{"34067-9": "helps to reduce difficulty in falling asleep", "34068-7": "adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years: do not use", "44425-7": "TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number", "50565-1": "In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.", "50567-7": "avoid alcoholic beverages take only at bedtime", "50568-5": "taking any other drugs.", "50569-3": "a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma", "50570-1": "in children under 12 years of age", "51727-6": "dibasic calcium phosphate dihydrate, FD & C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "51945-4": "sunmark ® *COMPARE TO UNISOM ® SLEEPTABS ® ACTIVE INGREDIENT NDC 70677-0068-1 sleep aid DOXYLAMINE SUCCINATE 25 mg Nighttime Sleep-Aid One tablet per dose 32 TABLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®. 50844 REV1120B38627 Distributed by McKesson Corp., via Strategic Sourcing Services, LLC Memphis, TN38141 © 2003 McKesson Corporation www.sunmarkbrand.com Money Back Guarantee Sunmark 44-386", "53413-1": "Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday", "53414-9": "ask a health professional before use.", "55105-1": "Nighttime sleep-aid", "55106-9": "Doxylamine succinate 25 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:53.033147 · Updated: 2026-02-15T12:05:52.880886