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Unisom SleepTabs by Chattem, Inc.

Medically reviewed on April 17, 2018

Dosage form: tablet
Ingredients: DOXYLAMINE SUCCINATE 25mg
Labeler: Chattem, Inc.
NDC Code: 41167-0060

Unisom SleepTabs

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

UNISOM SLEEPTABS 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0060
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize13mm
FlavorImprint CodeUnisom
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0060-61 BLISTER PACK in 1 CARTON
18 TABLET in 1 BLISTER PACK
2NDC:41167-0060-72 BLISTER PACK in 1 CARTON
28 TABLET in 1 BLISTER PACK
3NDC:41167-0060-92 BLISTER PACK in 1 CARTON
316 TABLET in 1 BLISTER PACK
4NDC:41167-0060-33 BLISTER PACK in 1 CARTON
416 TABLET in 1 BLISTER PACK
5NDC:41167-0060-25 BLISTER PACK in 1 CARTON
516 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01806610/18/1978
Labeler - Chattem, Inc. (003336013)

 
Chattem, Inc.

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Further information

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

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