Sleep Aid by L.N.K. International, Inc. / LNK International, Inc. LNK 44-386

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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

Do not use

in children under 12 years of age

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.

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 right away.

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

Other information

• store at controlled room temperature 20°-25°C (68°-77°F)
• see end flap for expiration date and lot number

Inactive ingredients

dibasic calcium phosphate dihydrate, 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 - 7/11

7/11 44-386

Principal Display Panel - CVS Health 

CVS Health 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 pharmacy

Freds pharmacy 44-386

Principal Display Panel - Healthmart

HealthMart 44-386

Principal Display Panel - HEB

HEB 44-386

Principal Display Panel - Kirkland

Kirkland 44-386

Principal Display Panel - Kroger

Kroger 44-386

Principal Display Panel - Leader

Leader 44-386

Principal Display Panel - Meijer

Meijer 44-386

Principal Display Panel - Nocto

Nocto 44-386

Principal Display Panel - Quality Plus

Rite Aid 44-386

Principal Display Panel - Rite Aid 

Rite Aid 44-386

Principal Display Panel - Sunmark

Sunmark 44-386

Principal Display Panel - Signature Care

Signature care 44-386

Principal Display Panel - Bulk blister label Magno Humphries

Magno Humphries 44-386

SLEEP AID 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-952
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (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: 50844-952-22	3 in 1 CARTON	04/11/2002
1		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50844-952-27	2 in 1 CARTON	04/11/2002
2		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 50844-952-96	2 in 1 CARTON	04/11/2002
3		96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 50844-952-46	1 in 1 CARTON	04/11/2002
4		96 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 50844-952-19	1 in 1 CARTON	04/11/2002
5		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 50844-952-90	32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/11/2002
7	NDC: 50844-952-08	1 in 1 CARTON	04/11/2002
7		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8	NDC: 50844-952-26	1000 in 1 BOX	04/11/2002
8		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC: 50844-952-00	2 in 1 PACKAGE	04/11/2002
9		96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
10	NDC: 50844-952-21	1 in 1 CARTON	04/11/2002
10		16 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

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

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(50844-952)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(50844-952)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	pack(50844-952)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	pack(50844-952)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(50844-952)

Revised: 9/2021

Document Id: 09cc14a2-9eed-4d42-92a1-f0adfb912107

34390-5

Set id: 5e13049d-2491-491b-a49c-de6a40ce0f1d

Version: 14

Effective Time: 20210925