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Sleep Aid

Rite Aid

Rite Aid 44-386


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Sleep Aid 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

Sleep Aid
Product Packaging

Sleep Aid

Doxylamine succinate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11822-0386
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOXYLAMINE SUCCINATE DOXYLAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C BLUE NO. 1
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
BLUE 10 mm 44;386 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 48 in 1 BLISTER PACK
2 32 in 1 BLISTER PACK
3 NDC:11822-0386-7 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040564 2001-04-11


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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