SLEEP AID- doxylamine succinate tablet
L.N.K. International, Inc.

----------

LNK 44-386

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have

glaucoma
a breathing problem such as asthma, emphysema or chronic bronchitis
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

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- CVS

CVS 44-386

Principal Display Panel - Equaline

Equaline 44-386

Principal Display Panel - Equate

Equate 44-386

Principal Display Panel - Exchange Select

Exchange Select 44-386

Principal Display Panel - Freds

Freds 44-386

Principal Display Panel - HealthCare

HealthCare 44-386

Principal Display Panel - HEB

HEB 44-386

Principal Display Panel - Kirkland

Kirkland 44-386

Principal Display Panel - Leader

Leader 44-386

Principal Display Panel - Meijer

Meijer 44-386

Principal Display Panel - Health Mart

Health Mart 44-386

Principal Display Panel - Sunmark

Sunmark 44-386

Principal Display Panel - Rite Aid

Rite Aid 44-386

Principal Display Panel - Signature Care

Signature Care 44-386

SLEEP AID
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-837
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44;386
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50844-837-22	3 in 1 CARTON	04/11/2002
1		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:50844-837-27	2 in 1 CARTON	04/11/2002
2		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:50844-837-19	1 in 1 CARTON	04/11/2002
3		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:50844-837-71	2 in 1 CARTON	04/11/2002
4		96 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:50844-837-46	1 in 1 CARTON	04/11/2002
5		96 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:50844-837-87	32 in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT	ANDA040564	04/11/2002

Labeler - L.N.K. International, Inc. (038154464)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(50844-837)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(50844-837)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(50844-837)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(50844-837)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(50844-837)

Revised: 1/2018

Document Id: 1b5f2e97-bfc0-4923-a792-01125a2bb5b7

Set id: cee3e1e3-31df-4e9c-98cb-6f4cc3cdc25d

Version: 1

Effective Time: 20180109

L.N.K. International, Inc.