Active Ingredient (In Each Tablet)
Doxylamine succinate 25 mg
Nighttime Sleep Aid Tablet
FDA Label NDC 69842-386
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Nighttime Sleep Aid (NDC 69842-386). 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, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Ask A Doctor Before Use If You Have
- glaucoma
- a breathing problem such as asthma, emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking any other drugs.
When Using This Product
- avoid alcoholic beverages
- 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 a 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 (1-800-222-1222) right away.
Directions
- adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
- children under 12 years: do not use
Other Information
- store at controlled room temperature 20°-25°C (68°-77°F)
- see end flap for expiration date and lot number
Inactive Ingredients
dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal Display Panel
♥︎CVSHealth™
Compare to the active ingredient
in Unisom® SleepTabs®*
Tablets
Nighttime
Sleep-Aid
DOXYLAMINE SUCCINATE TABLETS, 25 mg
Nighttime sleep-aid
Helps to reduce difficulty in falling asleep
Actual Bottle Size on Side Panel
2 x 96 TABLETS
One tablet per dose
192 TABLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
50844 REV0718A38646
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Cvs Health 44-386 (Cvs 44 386 1) 
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