FDA Label for 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
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product The Kroger Co.. 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 right away (1-800-222-1222).
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 at 15-30°C (59-86°F)
Inactive Ingredients
edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol-sorbitan
*contain one or more of these ingredients
Questions Or Comments?
Call 1-800-632-6900
Principal Display Panel
COMPARE TO the active ingredient in UNISOM® SLEEPGELS® **See back panel
MAXIMUM STRENGTH
Sleep-Aid Softgels
Diphenhydramine HCI, 50 mg
Nighttime Sleep Aid
Safe, Non-Habit Forming
SOFTGELS
ONE SOFTGELS PER DOSE
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
**UNISOM® SLEEPGELS® IS A REGISTERED TRADEMARK OF CHATTEM, INC., CHATTANOOGA, TN 37409. CHATTEM,INC., IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.
DISTRIBUTED BY: THE KROGER CO., CINCINNATI, OHIO 45202
Package Label
KROGER Sleep-Aid Softgels
* Please review the disclaimer below.