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Unisom SleepTabs by Chattem, Inc.

Dosage form: tablet
Ingredients: DOXYLAMINE SUCCINATE 25mg
Labeler: Chattem, Inc.
NDC Code: 41167-0063

Unisom SleepTabs

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

UNISOM SLEEPTABS 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0063
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize13mm
FlavorImprint CodeUnisom;ST
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0063-51 BLISTER PACK in 1 CARTON
116 TABLET in 1 BLISTER PACK
2NDC:41167-0063-61 BOTTLE, PLASTIC in 1 CARTON
232 TABLET in 1 BOTTLE, PLASTIC
3NDC:41167-0063-71 BOTTLE, PLASTIC in 1 CARTON
348 TABLET in 1 BOTTLE, PLASTIC
4NDC:41167-0063-81 BOTTLE, PLASTIC in 1 CARTON
480 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016701/15/2016
Labeler - Chattem, Inc. (003336013)

 
Chattem, Inc.

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Medically reviewed on Feb 16, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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