UNISOM SLEEPTABS- doxylamine succinate tablet 
Chattem, Inc.

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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

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

Other information

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: 1-866-844-2798

PRINCIPAL DISPLAY PANEL

Unisom Sleeptabs
Doxylamine succinate
25 mg

Nighttime Sleep-Aid
80 Tablets

PRINCIPAL DISPLAY PANEL 
Unisom Sleeptabs
Doxylamine succinate
25 mg
80 Tablets

UNISOM SLEEPTABS 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0063
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize13mm
FlavorImprint Code Unisom;ST
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0063-51 in 1 CARTON01/15/2016
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-0063-61 in 1 CARTON01/15/2016
232 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:41167-0063-71 in 1 CARTON01/15/2016
348 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:41167-0063-81 in 1 CARTON01/15/2016
480 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016701/15/2016
Labeler - Chattem, Inc. (003336013)

Revised: 5/2018
Document Id: 682e5524-9adb-4b03-921b-61e331a4d0c0
Set id: f591d52f-5610-4517-a96f-1ed63deb00bc
Version: 3
Effective Time: 20180502
 
Chattem, Inc.