SLEEP AID- doxylamine succinate tablet 
Rite Aid Corporation

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Rite Aid 44-386-Bisect-Delisted

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

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
  • 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

RITE
AID
PHARMACY®

*Compare to the active ingredient
in Unisom® Sleep Tabs®

sleep aid 
doxylamine succinate 25 mg
nighttime sleep aid

helps to reduce
difficulty falling asleep

safe & effective

go to sleep fast!

just one tablet per dose

easy to swallow

actual size
easy to swallow

48 TABLETS

TAMPER EVIDENT: DO NOT USE IF
CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Chattem,
Inc., owner of the registered trademark Unisom®
SleepTabs®.
50844     REV0513A38622

DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011

IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

Rite Aid 44-386

Rite Aid 44-386

SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0386
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
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:11822-0386-26 in 1 CARTON04/11/200208/01/2022
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11822-0386-74 in 1 CARTON04/11/200211/30/2017
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/200208/01/2022
Labeler - Rite Aid Corporation (014578892)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(11822-0386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(11822-0386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(11822-0386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(11822-0386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(11822-0386)

Revised: 11/2019
Document Id: 818ec1f0-8a6c-49ca-bc4c-390af198f051
Set id: 99883c0a-4152-440e-b626-4af6ed07a2ff
Version: 7
Effective Time: 20191111
 
Rite Aid Corporation