Active Ingredient (In Each Tablet)
Doxylamine succinate 25 mg
Unisom Sleeptabs Tablet
FDA Label NDC 41167-0608
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Unisom Sleeptabs (NDC 41167-0608). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nighttime sleep-aid
Use
■ helps to reduce difficulty in falling asleep
Warnings
See carton for 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 Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
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
Other Information
■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
■ store at controlled room temperature 20°-25°C (68°-77°F)
■ see end flap for expiration date and lot number
■ use by expiration date on package
Inactive Ingredients
dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
1-866-844-2798 Monday - Friday 8am-6pm ET
Principal Display Panel
Unisom
SleepTabs
Doxylamine succinate tablets, 25 mg
NIGHTTIME SLEEP-AID
Unisom Sleeptabsdoxylamine Succinate Tablets, 25 mgnighttime Sleep-aid (Unisom Sleep Tabs 2 01)
* Please review the disclaimer below.
