Active Ingredient (In Each Softgel)
Diphenhydramine HCl 50 mg
Sleep Aid Capsule
FDA Label NDC 63868-415
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Sleep Aid (NDC 63868-415). 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 softgel), purpose, use, do not use, ask a doctor before use if, 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- 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
avoid alcoholic drinks.
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
- adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Other Information
- store between 15-30°C (59-86°F)
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink
Questions Or Comments?
Call 800-935-2362 Monday-Friday 9AM-5PM EST
Principal Display Panel
†Compare to the Active Ingredient in Unisom® SleepGels®
Sleep-Aid Maximum Strength
Nighttime Sleep-Aid
Diphenhydramine HCl, 50 mg
Help to Reduce Difficulty Falling Asleep
Softgels
†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAPIS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
Product Label
QUALITY CHOICE Maximum Strength Sleep-Aid
* Please review the disclaimer below.
