UNISOM SLEEPTABS- doxylamine succinate tablet

Unisom SleepTabs by

Drug Labeling and Warnings

Unisom SleepTabs by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

• helps to reduce difficulty in falling asleep

Warnings

Do not use

in children under 12 years of age

Ask a doctor before use if you have

• a breathing problem such as asthma, emphysema or chronic bronchitis
  
• glaucoma
  
• 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

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  
• 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.

Directions

• adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  
• children under 12 years of age: do not use

Other information

• store at 20 - 25ºC (68 - 77ºF)

Inactive ingredients

dibasic calcium phosphate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate

PRINCIPAL DISPLAY PANEL

Value Size
Unisom® SleepTabs®
Doxylamine succinate tablets, 25 mg 
NIGHTTIME SLEEP-AID
48 Tablets
One Tablet per dose

INGREDIENTS AND APPEARANCE

UNISOM SLEEPTABS 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0060
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	OVAL	Size	13mm
Flavor		Imprint Code	Unisom
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0060-6	1 in 1 CARTON	10/18/1978	12/02/2017
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-0060-7	2 in 1 CARTON	10/18/1978	01/01/2019
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-0060-9	2 in 1 CARTON	10/18/1978	01/15/2018
3		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 41167-0060-3	3 in 1 CARTON	10/18/1978	01/15/2018
4		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 41167-0060-2	5 in 1 CARTON	10/18/1978	01/15/2018
5		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
NDA	NDA018066	10/18/1978	09/01/2019

Labeler - Chattem, Inc. (003336013)