NIGHTTIME SLEEP AID- doxylamine succinate tablet

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by GREAT LAKES WHOLESALE, MARKETING, & SALES, INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Uses

helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have

• 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

taking any other drugs. 

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 a 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 (1-800-222-1222) right away.

Directions

• 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

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
• store at controlled room temperature 20º-25ºC (68º-77ºF)
• see end flap for expiration date and lot number 

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

HEALTHCARE™
NDC: 64092-350-08

Nighttime
Sleep-Aid
Doxylamine succinate 25 mg

Go to Sleep Fast
Safe and Effective
Dosage: 1 Tablet

*Compare to the active ingredient in Unisom® SleepTabs®

8 TABLETS

* This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
50844       REV0513D38619

Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
www.glwholesale.com

HEALTHCARE GUARANTEE
If you are not completely satisfied with this product, regardless of reason, return your unused portion to Great Lakes Wholesale for a full refund

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Healthcare 44-386

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64092-350
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44;386
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64092-350-08	1 in 1 CARTON	04/11/2002	08/01/2022
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040564	04/11/2002	08/01/2022

Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(64092-350)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(64092-350)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(64092-350)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(64092-350)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(64092-350)