Unisom SleepTabs

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Unisom SleepTabs
Generic name
DOXYLAMINE SUCCINATE
Manufacturer
Chattem, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
7ae32d74-76a0-47e2-9e5c-812426413c4e
SPL ID
d16a629c-c038-4ab2-a330-9df512db0288
Version
1
Effective date
2026-03-25
Source export date
2026-11-06
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:39:19
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings S ee carton fo r complete 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 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 rea ch of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.