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

Unisom® SleepTabs®

Doxylamine succinate tablets Nighttime Sleep-Aid

Drug Facts

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Uses

• 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

• 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 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 68º to 77ºF (20º to 25ºC)
  
• retain in carton until time of use

Inactive ingredients

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

Questions or comments: 1-800-633-1610

PRINCIPAL DISPLAY PANEL

Unisom Sleeptabs
Doxylamine succinate
25 mg

Nighttime Sleep-Aid
80 Tablets

INGREDIENTS AND APPEARANCE

UNISOM SLEEPTABS 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0063
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0063-5	1 in 1 CARTON	01/15/2016
1		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-0063-6	1 in 1 CARTON	01/15/2016
2		32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 41167-0063-7	1 in 1 CARTON	01/15/2016
3		48 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 41167-0063-8	1 in 1 CARTON	01/15/2016
4		80 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	ANDA040167	01/15/2016

Labeler - Chattem, Inc. (003336013)