Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameDOXYLAMINE SUCCINATE
Labeler / manufacturerAmazon.com Services LLC
RouteORAL
Drug classDrug class not supplied in source label
Product NDC72288-432
Label effective date2026-09-02
Official product label reference
Sleep Aid — Amazon.com Services LLC
This page contains 15 source sections for DOXYLAMINE SUCCINATE, oral route. Label set c4509e0a-cb9d-454c-a67b-812a0ba62be1, version 2.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Use • helps to reduce difficulty in falling asleep
Purpose
Purpose Nighttime sleep-aid
Dosage and administration — label text
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
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 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).
Active ingredient
Active ingredient (in each tablet) Doxylamine succinate 25 mg
Do not use
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
Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist
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
While using this medicine
When using this product • avoid alcoholic beverages • do not drive a motor vehicle or operate machinery • take only at bedtime
When to stop use and seek help
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.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
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).
Storage and handling
Other information • store at 20-25°C (68-77°F) • Keep carton. It contains important information.
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.