Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Sleep Aid
FDA Label NDC 30142-367
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 30142-367). 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 caplet), purpose, uses, 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
Uses
- for relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Do Not Use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
avoid alcoholic beverages.
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than 2 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
- do not take more than directed
- adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
- children under 12 years: do not use
Other Information
- each caplet contains: calcium 30 mg
- protect from moisture
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-800-632-6900
Principal Display Panel
COMPARE TO the active ingredient of SIMPLY SLEEP® *See bottom panel
NDC 30142-367-12
Kroger®
Nighttime
Sleep Aid
Diphenhydramine HCI 25 mg
Nighttime Sleep-Aid
Non-Habit
Forming
Does Not Contain
Pain Reliever
actual size
100 CAPLETS
OUR PHARMACIST RECOMMENDED
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Simply Sleep® is a registered trademark of Johnson & Johnson, New Brunswick, NJ 08933. Johnson & or this product.
Our Brands, Our Guarantee.
Love It or Your Money Back.
www.kroger,com
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
FOR MORE PRODUCT INFORMATION, SCAN UPC
USING YOUR KROGER APP
OR CALL 800-632-6900
50844 ORG101936712
44-367 (Kroger 44 367 1)
* Please review the disclaimer below.
