NOCTO SLEEP AID- doxylamine succinate tablet

Nocto Sleep Aid by

Drug Labeling and Warnings

Nocto Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Belmora LLC. 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

• 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 IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  
• 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 1-888-779-2877 M-F 9AM-5PM EST

Principal display panel

Belmora LLC

NDC: 27854-375-01

NOCTO®

SLEEP AID
Doxylamine Succinate 25 mg
Nighttime Sleep-Aid

24 Tablets
Actual Size

One Tablet Per Dose Easy to Swallow

Helps to reduce
difficulty in falling asleep

Wake up refreshed with Nocto

NOT TO BE SOLD IF PACKAGE IS TORN OR MISSING DOSAGE INFORMATION.

Distributed by: Belmora LLC, 2011 Crystal Dr. Suite 400, Arlington, VA 22202

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

Nocto 44-386

INGREDIENTS AND APPEARANCE

NOCTO SLEEP AID 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-375
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: 27854-375-01	1 in 1 CARTON	10/31/2019
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040564	10/31/2019

Labeler - Belmora LLC (112753244)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(27854-375)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(27854-375)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(27854-375)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(27854-375)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(27854-375)