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Sleep Aid by Rite Aid

Dosage form: tablet
Ingredients: DOXYLAMINE SUCCINATE 25mg
Labeler: Rite Aid
NDC Code: 11822-0386

Rite Aid 44-386

Active ingredient(s)

 Doxylamine succinate 25 mg

Purpose

 Nighttime sleep-aid

Use(s)

 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

 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.

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 temperate 20º-25ºC (68º-77ºF) [See USP]
  • 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 glucolate

Questions or comments?

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

Principal Display Panel

RITE

AID®

PHARMACY

Doxylamine Succinate Tablets, 25 mg

NIGHT

Sleep Aid

DOSAGE: 1 TABLET

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

50844    REV0610A38622

DISTRIBUTED BY:

Rite Aid

30 Hunter Lane, Camp Hill, PA 17011

Product Packaging

SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0386
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code44;386
Contains    
Packaging
#Item CodePackage Description
1NDC:11822-0386-21 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
148 TABLET (48 TABLET) in 1 BLISTER PACK
2NDC:11822-0386-71 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
232 TABLET (32 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/2001
Labeler - Rite Aid (014578892)

Revised: 08/2011
 
Rite Aid

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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