Medication Guide App

Unisom SleepTabs

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
ColorBLUEScoreno score
ShapeOVALSize13mm
FlavorImprint CodeU
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0060-61 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
18 TABLET (8 TABLET) in 1 BLISTER PACK
2NDC:41167-0060-72 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
216 TABLET (16 TABLET) in 1 BLISTER PACK
3NDC:41167-0060-94 BLISTER PACK (4 BLISTER PACK) in 1 CARTON
332 TABLET (32 TABLET) in 1 BLISTER PACK
4NDC:41167-0060-36 BLISTER PACK (6 BLISTER PACK) in 1 CARTON
448 TABLET (48 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01806610/18/1978
Labeler - Chattem, Inc. (003336013)

Revised: 03/2014
 
Chattem, Inc.

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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