Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Kroger Nighttime Sleep Aid
FDA Label NDC 30142-116
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 Kroger Nighttime Sleep Aid (NDC 30142-116). 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, use, warnings, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, 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
for the relief of occasional sleeplessness
Warnings
Warnings
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
■ trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking
sedatives or tranquilizers
When Using This Product
■ avoid alcoholic drinks ■ drowsiness will occur
■ do not drive a motor vehicle or operate machinery
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than 2
weeks. Insomnia may be a symptom of serious
underlying medical illness.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional
before use.
Other
Drug Facts (continued)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
In case of overdose, get medical help or contact a
Poison Control Center right away. (1-800-222-1222)
Directions
| 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 23.52 mg
■ store between 20-25°C (68-77°F). Avoid high
humidity. Protect from light.
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium,
dicalcium phosphate, FD&C Blue #1, FD&C Blue #2,
lecithin, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polyvinyl alcohol, talc, titanium
dioxide
Otc - Questions
Questions or comments? 1-800-632-6900
Principal Display Panel
COMPARE TO the active ingredient of SIMPLY SLEEP ® NIGHTTIME SLEEP AID CAPLETS*
Kroger
NDC 30142-116-01
Nighttime Sleep-Aid
Diphenhydramine HCl, 25mg
Does NOT contain Pain Reliever
For a Restful
Night's Sleep
SAFE, NON-HABIT FORMING
100
MINI-CAPLETS
actual size
*Simply Sleep® is a registered trademark of Johnson & Johnson, New Brunswick, NJ 08933-7001. Johnson & Johnson is not affiliated with The Kroger Co. or this product.
* Please review the disclaimer below.
