Active Ingredient (In Each Tablet)
Doxylamine succinate 25 mg
Sleep Aid Tablet
FDA Label NDC 30142-386
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Sleep Aid (NDC 30142-386). 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 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
- 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?
1-800-632-6900
Principal Display Panel
COMPARE TO the active ingredient
of UNISOM® SLEEPTABS® *See back panel
NDC 30142-386-27
Kroger®
Nighttime Sleep-Aid
Sleep Aid
Doxylamine Succinate
Tablets, 25 mg
Nighttime Sleep-Aid
Actual Size
One tablet per dose
32 TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*Unisom® and SleepTabs® are registered trademarks of Chattem, Inc., Chattanooga, TN 37409. Chattem, Inc. is not affiliated with The Kroger Co. or this product.
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
FOR MORE PRODUCT INFORMATION, SCAN UPC
USING YOUR KROGER APP OR CALL 800-632-6900
50844 ORG071838627
Kroger 44-386 (Kroger 44 386 1)
* Please review the disclaimer below.
