Night Time 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

Use

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
• difficulty in urination due to enlargement of the prostate gland
• glaucoma

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking any other drugs.

When using this product

OTC - WHEN USING SECTION

• avoid alcoholic beverages
• take only at bedtime

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 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 right away. [1-800-222-1222]

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Other information

STORAGE AND HANDLING SECTION

• store at 20°-25°C (68° and 77° F)
• protect from excessive moisture
• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-630-8895

SPL UNCLASSIFIED SECTION

Distributed by:

ADVANCED RX LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Unisom ^®Sleeptabs ^®

NDC 80513-371-25

Night Time Sleep Aid

Doxylamine Succinate 25 mg

225 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Unisom ^®Sleeptabs ^®.

Good Neighbor 44-386

Good Neighbor 44-386

DailyMed RxNorm Mappings#

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Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

• Night Time Sleep Aid
• Doxylamine Succinate
• DIBASIC CALCIUM PHOSPHATE DIHYDRATE
• FD&C BLUE NO. 1 ALUMINUM LAKE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• SODIUM STARCH GLYCOLATE TYPE A
• DOXYLAMINE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

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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#

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Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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