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 CVS PHARMACY, 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
• difficulty in urination due to enlargement of the 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 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 20º-25ºC (68º-77ºF)
• 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

♥︎CVSHealth™

Compare to the active ingredient
in Unisom® SleepTabs®*

Tablets

Nighttime
Sleep-Aid
DOXYLAMINE SUCCINATE TABLETS, 25 mg

Nighttime sleep-aid

Helps to reduce difficulty in falling asleep

Actual Bottle Size on Side Panel

2 x 96 TABLETS
One tablet per dose

192 TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
50844       REV0718A38646

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com®    1-800-SHOP-CVS

✓CVS Quality
Money Back Guarantee

CVS Health 44-386

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-386
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 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
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: 69842-386-96	2 in 1 CARTON	07/20/2019
1		96 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040564	07/20/2019

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(69842-386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(69842-386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(69842-386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(69842-386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(69842-386)