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Doxylamine Succinate

OTC Oral RxCUI 1101446
Contents

Overview

Active ingredient
Doxylamine Succinate
Route
Oral
Label date
2026-03-24

Indications and usage

Use

  • helps to reduce difficulty in falling asleep

Purpose

Nighttime sleep-aid

Dosage and administration

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

Warnings

Do not use

  • in children under 12 years of age
  • with any other product containing doxylamine
  • unless you have time for a full night’s sleep 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 Ask a doctor or pharmacist before use if you are taking
  • a sedative or any other sleep-aid
  • tranquilizers
  • any other antihistamines
  • any other drugs When using this product
  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • 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 (1-800-222-1222).

Do not use

  • in children under 12 years of age
  • with any other product containing doxylamine
  • unless you have time for a full night’s sleep

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are taking

  • a sedative or any other sleep-aid
  • tranquilizers
  • any other antihistamines
  • any other drugs

When using this product

this product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • take only at bedtime

Stop use and ask a doctor if

and ask a doctor if

  • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Active ingredient (label)

(in each tablet) Doxylamine succinate 25 mg

Inactive ingredients

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

Storage and handling

Other information

  • store at 20-25°C (68-77°F)
  • keep carton. It contains important information.

Keep out of reach of children

of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).