Active Ingredient
(in each softgel)
Diphenhydramine HCI 50 mg
Unisom Sleepgels Nighttime Sleep-aid Capsule, Liquid Filled
FDA Label NDC 41167-0061
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Unisom Sleepgels Nighttime Sleep-aid (NDC 41167-0061). 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, 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
- 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
- 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 persist continuously for more than 2 weeks. Insomnia may be a symptom of 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
- adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Inactive Ingredients
blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide, water (245-189)
Principal Display Panel
Unisom
#1 PHARMACIST RECOMMENDED INGREDIENT*
SLEEPGELS
Diphenhydramine HCI SoftGels, 50 mg
NIGHTTIME SLEEP-AID
32 SOFTGELS LIQUID FILLED
JUST ONE SOFTGEL PER DOSE
Principal Display Panelunisom#1 Pharmacist Recommended Ingredient*sleepgelsdiphenhydramine Hci Softgels, 50 mgnighttime Sleep-aid32 Softgels Liquid Filledjust One Softgel Per Dose (Unisom Sleepgels Nighttime 01)
* Please review the disclaimer below.
