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Sleep Aid by FRED'S, INC.

Dosage form: tablet
Ingredients: DOXYLAMINE SUCCINATE 25mg
Labeler: FRED'S, INC.
NDC Code: 55315-986

Freds 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
  • 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

fred's
Pharmacy

NDC 55315-986-27    

Compare to the active ingredient in: Unisom® SleepTabs®* 

Sleep Aid
Doxylamine succinate, 25 mg
Nighttime Sleep-Aid

Fall Asleep Fast / Safe
Easy to Swallow

Actual Bottle Size on Side Panel
Package Contains One Bottle

32 TABLETS
ONE TABLET PER DOSE

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE 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    REV0513E38627

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

Freds 44-386

SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-986
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code44;386
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-986-272 BLISTER PACK in 1 CARTON
116 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/2002
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55315-986)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-986)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(55315-986)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(55315-986)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(55315-986)

 
FRED'S, INC.

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Medically reviewed on May 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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