SLEEP AID- doxylamine succinate tablet

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, 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

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

• 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

RITE
AID
PHARMACY®

*Compare to the active ingredient
in Unisom® Sleep Tabs®

sleep aid 
doxylamine succinate 25 mg
nighttime sleep aid

helps to reduce
difficulty falling asleep

safe & effective

go to sleep fast!

just one tablet per dose

easy to swallow

actual size
easy to swallow

48 TABLETS

TAMPER EVIDENT: DO NOT USE IF
CARTON 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     REV0513A38622

DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011

IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

Rite Aid 44-386

INGREDIENTS AND APPEARANCE

SLEEP AID 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0386
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0386-2	6 in 1 CARTON	04/11/2002	08/01/2022
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11822-0386-7	4 in 1 CARTON	04/11/2002	11/30/2017
2		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 - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(11822-0386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(11822-0386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(11822-0386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(11822-0386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(11822-0386)