sleep aid

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Doxylamine succinate 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

helps to reduce difficulty in falling asleep

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drugs.

When using this product

OTC - WHEN USING SECTION

• take only at bedtime
• avoid alcoholic beverages

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
• do not give to children under 12 years of age.

Other information

STORAGE AND HANDLING SECTION

• 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Health Mart®

NDC 62011-0344-1

Compare to Unisom®
SleepTabs® active ingredient*

Sleep Aid Tablets

Doxylamine Succinate 25 mg
Nighttime Sleep Aid

Fall Asleep Fast/Safe
One Tablet Per Dose

Easy to Swallow

Actual Size

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        REV0513A38627

McKESSON

Another Quality Product
Distributed by McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
healthmart.com

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

• sleep aid nighttime
• doxylamine succinate
• DOXYLAMINE
• FD&C BLUE NO. 1
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• ANHYDROUS DIBASIC CALCIUM PHOSPHATE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.