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Sleep Aid

H E B

HEB Sleep Aid Tablets Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Sleep Aid Uses

  • helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Do not give

to children under 12 years of age

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 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 and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • children under 12 years of age: do not use
  • store at 68°-77°F (20°-25°C)
  • retain in carton until time of use
  • see carton end panel for lot number and expiration date

Inactive ingredients

anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Unisom® SleepTabs®

SLEEP - AID

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

ACTUAL SIZE

Proven Effective

Just One Tablet Per Dose

GLUTEN FREE

Sleep Aid
Sleep - Aid Carton Image 1 Sleep - Aid Carton Image 2

Sleep Aid

Doxylamine succinate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37808-441
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
BLUE 10 mm L441 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 16 in 1 BLISTER PACK
2 NDC:37808-441-64 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040167 1998-05-06


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