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
2026-10-12
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/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:17:36
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.