Active Ingredient (In Each Tablet)
Doxylamine succinate 25 mg
Sleep Aid Tablet
FDA Label NDC 51316-368
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 Woonsocket Prescription Center, Incorporated for the product Sleep Aid (NDC 51316-368). 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, do not 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, 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
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 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
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
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NDC 51316-368-22
actual size
SLEEP-AID
Doxylamine Succinate Tablets, 25 mg
Nighttime Sleep-Aid
Compare to Unisom® SleepTabs® active ingredient*
Helps to reduce difficulty in falling asleep
48 TABLETS
(ONE TABLET PER DOSE)
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Chattem, Inc.,
owner of the registered trademark Unisom® SleepTabs®.
50844 ORG012338622
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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