NIGHT TIME SLEEP AID- doxylamine succinate tablet

Night Time Sleep Aid by

Drug Labeling and Warnings

Night Time Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Advanced Rx 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 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. [1-800-222-1222]

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 20°-25°C (68° and 77° F)
• protect from excessive moisture
• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive ingredients

dicalcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions?

call toll-free 1-800-630-8895

SPL UNCLASSIFIED SECTION

Distributed by:

ADVANCED RX LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A

PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Unisom ®Sleeptabs ®

NDC: 80513-371-25

Night Time Sleep Aid

Doxylamine Succinate 25 mg

225 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Unisom ®Sleeptabs ®.

Good Neighbor 44-386

Good Neighbor 44-386

INGREDIENTS AND APPEARANCE

NIGHT TIME SLEEP AID 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-371
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 (UNII: H8AV0SQX4D)

Product Characteristics
Color	blue (light 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: 80513-371-25	225 in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040564	08/27/2004

Labeler - Advanced Rx LLC (042795108)