FDA Label for Unisom Sleepgels Nighttime Sleep-aid
View Indications, Usage & Precautions
Unisom Sleepgels Nighttime Sleep-aid Product Label
The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
(in each softgel)
Diphenhydramine HCI 50 mg
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
* Please review the disclaimer below.