FDA Label for Nighttime Sleep Aid
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Nighttime Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Wr Group, 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 HCl 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 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
Principal Display Panel
†Compare to the Active Ingredient in Unisom® SleepGels®
NON HABIT-FORMING
NIGHTTIME
Sleep Aid
Diphenhydramine HCI 50 mg
FALL ASLEEP FAST | SLEEP SOUNDLY
WAKE UP REFRESHED
SOFTGELS**
ONE SOFTGEL PER DOSE
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
**This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.
MANUFACTURED FOR:
KOLBE & SCHMITT
9160 E. BAHIA DR. SCOTTSDALE, AZ 85260 USA
Package Label
KOLBE & SCHMITT Night Time Sleep-Aid
* Please review the disclaimer below.