Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Sleep Aid Tablet, Film Coated
FDA Label NDC 55319-367
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services Inc for the product Sleep Aid (NDC 55319-367). 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, use, 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
Use
for relief of occasional sleeplessness
Do Not Use
- in 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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- drowsiness will occur
- avoid alcoholic drinks
- 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 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 (1-800-222-1222) 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 28 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- 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, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide
Questions Or Comments?
Call 1-800-426-9391
Principal Display Panel
FAMILY
wellness™
COMPARE TO THE ACTIVE
INGREDIENT OF SIMPLY SLEEP®*
Nighttime
Sleep Aid
Diphenhydramine HCl / Nighttime Sleep-Aid
Safe, Non-Habit Forming
Does Not Contain Pain Reliever
24 CAPLETS 25 mg each
ACTUAL SIZE
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 McNeil
Consumer Healthcare, owner of the registered trademark
Simply Sleep®. 50844 REV0814C36708
Not 100% satisfied?
Return package and unused product within 30 days to any
Family Dollar store for a refund (with receipt) or exchange.
DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD, MATTHEWS, NC 28105 USA
Family Wellness 44-367 (Family Wellness 44 367 1)
* Please review the disclaimer below.
