Night Time Sleep Aid

SPL v2

SPL

SPL Set ID db8b730a-1553-4682-96bf-41e670ed0347

Route

ORAL

Published

Effective Date 2024-08-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Doxylamine (25 mg)

Inactive Ingredients

Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance

Imprint: 44;386 Shape: oval Color: blue Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2004-08-27

Description

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Doxylamine succinate 25 mg

Use

helps to reduce difficulty in falling asleep

Section 42229-5

Distributed by:

ADVANCED RX LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A

Section 51945-4

*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

Directions

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

Questions?

call toll-free 1-800-630-8895

Other Information

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.

Active Ingredient

Doxylamine succinate 25 mg

Inactive Ingredients

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

When Using This Product

avoid alcoholic beverages
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]

Ask A Doctor Before Use If You Have

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

you are taking any other drugs.

Structured Label Content

Use

helps to reduce difficulty in falling asleep

Section 42229-5 (42229-5)

Distributed by:

ADVANCED RX LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A

Section 51945-4 (51945-4)

*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

Purpose

Nighttime sleep-aid

Directions

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

Questions?

call toll-free 1-800-630-8895

Other Information (Other information)

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.

Active Ingredient (Active ingredient )

Doxylamine succinate 25 mg

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)

avoid alcoholic beverages
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]

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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 (Ask a doctor or pharmacist before use if)

you are taking any other drugs.

Advanced Ingredient Data

[{"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "helps to reduce difficulty in falling asleep", "42229-5": "Distributed by: ADVANCED RX LLC 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A", "51945-4": "*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", "Purpose": "Nighttime sleep-aid", "Directions": "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", "Questions?": "call toll-free 1-800-630-8895", "Other information": "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.", "Active ingredient ": "Doxylamine succinate 25 mg", "Inactive ingredients": "dicalcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "When using this product": "avoid alcoholic beverages 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]", "Ask a doctor before use if you have": "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": "you are taking any other drugs."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:38.242029 · Updated: 2026-03-14T23:07:45.169331