NIGHTTIME SLEEP AID- doxylamine succinate tablet 
CVS Pharmacy

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CVS 44-386

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • 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 a 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 (1-800-222-1222) right away.

Directions

  • adults: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • do not give to children under 12 years of age 

Other information

  • store at controlled room temperature 20º-25ºC (68º-77ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

♥︎CVSHealth™

Compare to the active ingredient
in Unisom® SleepTabs®*

Tablets

NDC 59779-863-46      

Nighttime
Sleep-Aid
DOXYLAMINE SUCCINATE, 25 mg

Nighttime sleep-aid

• Fall asleep fast
• Easy to swallow

Actual Bottle Size on Side Panel
Package Contains One Bottle

96 TABLETS
One tablet per dose

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
50844       REV0513A38646

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One CVS Drive, Woonsocket, RI 02895
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CVS 44-386

CVS 44-386

NIGHTTIME SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-863
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;386
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-863-223 in 1 CARTON04/11/200207/20/2022
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59779-863-461 in 1 CARTON04/11/200207/20/2022
296 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/200207/20/2022
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-863)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(59779-863)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(59779-863)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(59779-863)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(59779-863)

Revised: 6/2019
Document Id: 20a838b9-f967-400e-8b00-c6d23843b79f
Set id: acacdecc-cc25-405d-a0bb-6f0a891c4d02
Version: 10
Effective Time: 20190608
 
CVS Pharmacy