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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:41167-0063-52 BLISTER PACK in 1 CARTON
18 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)

Revised: 01/2016
 
Chattem, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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