UNISOM SLEEPTABS- doxylamine succinate tablet 
Chattem, Inc.

----------

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

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize13mm
FlavorImprint Code Unisom
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0060-61 in 1 CARTON10/18/197812/02/2017
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-0060-72 in 1 CARTON10/18/197801/01/2019
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41167-0060-92 in 1 CARTON10/18/197801/15/2018
316 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:41167-0060-33 in 1 CARTON10/18/197801/15/2018
416 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:41167-0060-25 in 1 CARTON10/18/197801/15/2018
516 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01806610/18/197809/01/2019
Labeler - Chattem, Inc. (003336013)

Revised: 10/1978
Document Id: ec9656f2-0b1b-4148-befb-57876134c2e6
Set id: d5e3015c-49ae-4288-a78f-17a141f26817
Version: 9
Effective Time: 19781018
 
Chattem, Inc.