DailyMed - NIGHTTIME SLEEP AID- doxylamine succinate tablet

NDC Code(s): 46122-788-15
Packager: Amerisource Bergen

Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 7, 2025

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

Active ingredient (in each tablet)
Doxylamine succinate 25 mg

Doxylamine succinate 25 mg

Close
Purpose
Nighttime sleep-aid

Nighttime sleep-aid

Close
Use
helps to reduce difficulty in falling asleep
- helps to reduce difficulty in falling asleep
Close
Warnings
Do not use - in children under 12 years of age - with any other product containing doxylamine - unless you have time for a full night’s sleep - Ask a doctor before use if you have - a ...
Do not use
- in children under 12 years of age
- with any other product containing doxylamine
- unless you have time for a full night’s sleep
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are

taking
- sedatives or any other sleep-aid
- tranquilizers
- any other antihistamines
- any other drugs
When using this product
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- 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.

Close
Directions
adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor - children under 12 years of age: do not use
- adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
- children under 12 years of age: do not use
Close
Other information
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 ...
- 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
Close
Inactive ingredients
dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

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

Close
Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Close
Principal display panel (What is this?)
Good - Neighbor - Pharmacy® *Compare to the active ingredient - in Unisom® SleepTabs® NDC 46122-788-15 - Nighttime Sleep Aid - Doxylamine succinate tablets 25 mg - Nighttime Sleep-Aid - • One ...

Good
Neighbor
Pharmacy®

*Compare to the active ingredient
in Unisom® SleepTabs®

NDC 46122-788-15

Nighttime Sleep Aid
Doxylamine succinate tablets 25 mg

Nighttime Sleep-Aid

• One tablet per dose

32 tablets

Actual Size

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 ORG012338627

Distributed By
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com

Good Neighbor 44-386

Close

INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(46122-788)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(46122-788) , pack(46122-788)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(46122-788)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(46122-788)

View All Sections

Published Date (What is this?)	Version	Files
Jun 9, 2025	3 (current)	download
Jun 10, 2024	2	download

	RxCUI	RxNorm NAME	RxTTY
1	1101446	doxylamine succinate 25 MG Oral Tablet	PSN
2	1101446	doxylamine succinate 25 MG Oral Tablet	SCD

Label: NIGHTTIME SLEEP AID- doxylamine succinate tablet

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: NIGHTTIME SLEEP AID- doxylamine succinate tablet

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

NIGHTTIME SLEEP AID- doxylamine succinate tablet

Number of versions: 2

NIGHTTIME SLEEP AID- doxylamine succinate tablet

NIGHTTIME SLEEP AID- doxylamine succinate tablet

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

NIGHTTIME SLEEP AID- doxylamine succinate tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.