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

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
  
• 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 (1-800-222-1222) 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

• 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
  

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

RITE
AID
PHARMACY

*Compare to the active ingredient in Unisom® SleepTabs®

sleep aid
doxylamine succinate 25 mg
nighttime sleep aid

helps to reduce
difficulty falling asleep
just one tablet per dose

easy to swallow

actual size
easy to swallow

48 TABLETS

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

SATISFACTION GUARANTEED

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

*This product is not manufactured or distributed by Chattem, Inc.,
owner of the registered trademark Unisom® SleepTabs®.
50844 REV0718B38622

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

Rite Aid 44-386

INGREDIENTS AND APPEARANCE

SLEEP AID 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-9386
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
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)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)

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: 11822-9386-2	3 in 1 CARTON	07/30/2019
1		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	07/30/2019

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(11822-9386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(11822-9386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(11822-9386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(11822-9386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(11822-9386)