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Unisom SleepTabs

Doxylamine Succinate · Tablet

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Unisom SleepTabs
Generic name
Doxylamine Succinate
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Chattem, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
9
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Doxylamine Succinate 25 mg/1 1094549 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
11

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Antihistamine [EPC] EPC All 15 members
Histamine Receptor Antagonists [MoA] MoA All 15 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
040167
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 18, 1996
Sponsor
PERRIGO
Products on application
1
Submissions recorded
14
Products approved under application 040167.
Product Trade name Form Strength Ingredient Status TE Flags
040167-001 DOXYLAMINE SUCCINATE TABLET DOXYLAMINE SUCCINATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 040167.
Type No. Action Status Date Review
Supplement 52 Manufacturing (CMC) Approved April 4, 2024 Unknown
Supplement 51 Manufacturing (CMC) Approved February 20, 2024 Unknown
Supplement 50 Labeling Approved October 6, 2023 Standard
Supplement 43 Labeling Approved March 6, 2015 Standard
Supplement 41 Manufacturing (CMC) Approved October 9, 2014 —
Supplement 33 Labeling Approved June 2, 2009 —
Supplement 31 Labeling Approved July 14, 2008 —
Supplement 6 Labeling Approved September 10, 2002 —
Supplement 5 Manufacturing (CMC) Approved October 4, 2001 —
Supplement 4 Manufacturing (CMC) Approved October 4, 2001 —
Supplement 3 Manufacturing (CMC) Approved January 21, 1999 —
Supplement 2 Manufacturing (CMC) Approved February 10, 1998 —
Supplement 1 Manufacturing (CMC) Approved February 10, 1998 —
Original application 1 Approved September 18, 1996 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260325). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260325 HUMAN OTC DRUG · 20260114

Indications and Usage

openFDA Drug Labeling

Use ■ helps to reduce difficulty in falling asleep

Purpose

openFDA Drug Labeling

Purpose Nighttime sleep-aid

Dosage and Administration

openFDA Drug Labeling

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

openFDA Drug Labeling

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.

Do Not Use

openFDA Drug Labeling

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

openFDA Drug Labeling

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

Stop Use

openFDA Drug Labeling

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.

Active Ingredient

openFDA Drug Labeling

Active i ngredient (in each tablet ) Doxylamine succinate 25 mg

Adverse event reports

Source: openFDA FAERS
7,688
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DOXYLAMINE SUCCINATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
41167-0063-5 41167-0063 Chattem, Inc. 1 BLISTER PACK in 1 CARTON (41167-0063-5) / 16 TABLET in 1 BLISTER PACK January 15, 2016
41167-0063-6 41167-0063 Chattem, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-6) / 32 TABLET in 1 BOTTLE, PLASTIC January 15, 2016
41167-0063-7 41167-0063 Chattem, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-7) / 48 TABLET in 1 BOTTLE, PLASTIC January 15, 2016
41167-0063-8 41167-0063 Chattem, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-8) / 80 TABLET in 1 BOTTLE, PLASTIC January 15, 2016
41167-0608-0 41167-0608 Chattem, Inc. 1 BLISTER PACK in 1 CARTON (41167-0608-0) / 16 TABLET in 1 BLISTER PACK March 16, 2026
41167-0608-1 41167-0608 Chattem, Inc. 1 BOTTLE in 1 CARTON (41167-0608-1) / 32 TABLET in 1 BOTTLE March 16, 2026
41167-0608-2 41167-0608 Chattem, Inc. 1 BOTTLE in 1 CARTON (41167-0608-2) / 48 TABLET in 1 BOTTLE March 16, 2026
41167-0608-3 41167-0608 Chattem, Inc. 1 BOTTLE in 1 CARTON (41167-0608-3) / 80 TABLET in 1 BOTTLE March 16, 2026
41167-0608-4 41167-0608 Chattem, Inc. 1 BLISTER PACK in 1 CARTON (41167-0608-4) / 4 TABLET in 1 BLISTER PACK March 16, 2026
41167-0063 41167-0063 Chattem, Inc. — January 15, 2016
41167-0608 41167-0608 Chattem, Inc. — March 16, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.