Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Sleep Aid Tablet, Film Coated
FDA Label NDC 36800-672
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Sleep Aid (NDC 36800-672). 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
- with any other product containing diphenhydramine, even one used on skin
- for children under 12 years of age
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 (50 mg) at bedtime if needed, or as directed by a doctor
- children under 12 years: do not use
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)
- use by expiration date on package
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 Or Comments?
1-888-423-0139
Principal Display Panel
TopCare
Health®
NDC 36800-672-06
COMPARE TO
VICKS® ZZZQUIL®
ACTIVE INGREDIENT*
NIGHTTIME
Sleep Aid
DIPHENHYDRAMINE HCl, 25 mg
NIGHTTIME SLEEP-AID
• Non-Habit Forming
• Not for Treating Pain, Cold or Flu
200 CAPLETS
•OUR PHARMACISTS RECOMMEND•
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0220 QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
QUALITY GUARANTEED
*This product is not manufactured or distributed by The Procter &
Gamble Company, owner of the registered trademark VICKS® ZzzQuil®.
50844 REV0419A67206
Topcare 44-672 (Topcare 44 672 1)
* Please review the disclaimer below.
