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OTC products · Product label record

Sleep Aid drug information

DOXYLAMINE SUCCINATE
COSTCO WHOLESALE CORPORATION · ORAL

Product NDC: 63981-986

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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 / manufacturerCOSTCO WHOLESALE CORPORATION
RouteORAL
Drug classDrug class not supplied in source label
Product NDC63981-986
Label effective date2026-08-28

Official product label reference

Sleep Aid — COSTCO WHOLESALE CORPORATION

This page contains 15 source sections for DOXYLAMINE SUCCINATE, oral route. Label set 74a728e1-9ca1-4219-9427-b503ab0480b4, version 12.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

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 sedatives or any other sleep-aid tranquilizers any other drugs any other antihistamines When using this product avoid alcoholic beverages take only at bedtime do not drive a motor vehicle or operate machinery 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.
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 sedatives or any other sleep-aid tranquilizers any other drugs any other antihistamines
While using this medicine
When using this product avoid alcoholic beverages take only at bedtime do not drive a motor vehicle or operate machinery
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.
Storage and handling
Other information use by expiration date on package store at controlled room temperature 20°-25°C (68°-77°F)
Inactive ingredient
Inactive ingredients dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions
Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Official sources and product identifiers

Substances listed: DOXYLAMINE SUCCINATE

RxNorm identifiers: 1101446

Package NDC codes

63981-986-96, 63981-986-44

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

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.

Source retrieved 2026-10-02. Read the source policy.