Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Nighttime Sleep Aid Tablet, Film Coated
FDA Label NDC 70677-1128
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Nighttime Sleep Aid (NDC 70677-1128). 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
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- 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?
Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
Principal Display Panel
NDC 70677-1128-1
Foster & Thrive™
COMPARE TO SIMPLY SLEEP®
ACTIVE INGREDIENT*
Nighttime Sleep Aid
Diphenhydramine HCl 25 mg
NIGHTTIME SLEEP-AID
Non-habit Forming
Helps You Fall Asleep
Not for treating Pain, Cold or Flu
ACTUAL SIZE
24 CAPLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Simply Sleep®.
50844 ORG101936708 Rev. 04/23
©2023 McKesson Corporation
Distributed by: McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141
Money Back Guarantee
www.fosterandthrive.com
Foster And Thrive 44-367 (Foster And Thrive 44 367 1)
* Please review the disclaimer below.
