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

Active Ingredient

Doxylamine succinate 25 mg

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

Structured Label Content

Active Ingredient (55106-9)

Doxylamine succinate 25 mg

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

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