Active Ingredient
Active ingredient (in each caplet)
Diphenhydramine HCl 25 mg
Sleep-aid, Circle K Tablet, Film Coated
FDA Label NDC 66715-5503
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Sleep-aid, Circle K (NDC 66715-5503). 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, purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
Nighttime sleep-aid
Uses
Uses
- for relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
Warnings
Otc - Do Not Use
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Otc - When Using
When using this product avoid alcoholic beverages.
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison
Control Center right away.
Directions
Directions
- do not take more than directed
- adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
- children under 12 years: do not use
Other Information
Other information
- each caplet contains: calcium 65 mg
- avoid excessive heat (greater than 100°F) or humidity
- 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
Inactive ingredients
corn starch, D&C red #27 aluminum lake, dibasic calcium
phosphate dihydrate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
Questions?
Questions? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)
Pdp [Lil' Drug Store Nighttime Sleep-Aid, 24Ct]
[caduceus]
*Compare to the Active Ingredient in
VICKS® ZzzQuil
®
Nighttime
Sleep-Aid
Diphenhydramine HCI 25 mg
Nighttime Sleep-Aid
[caplet image]
ACTUAL SIZE
- Non-Habit Forming
Not for treating Pain, Cold or Flu
24
Caplets
[Lil' Drug Store logo]
Pdp [Circle K Nighttime Sleep-Aid, 24Ct]
NON-HABIT FORMING
NOT FOR TREATING PAIN, COLD OR FLU
Compare to the active ingredient in
Vicks® ZzzQuil
®*
CIRCLE K™
nighttime
sleep-aid
Diphenhydramine HCI, 25 mg
Nighttime Sleep-Aid
[caplet image]
actual size
24 caplets
* Please review the disclaimer below.
