FDA Label for Maximum Strength Sleep Aid
View Indications, Usage & Precautions
Maximum Strength Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Kroger Company. 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.
Other
Drug Facts
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
GLUTEN FREE
Active Ingredient (In Each Softgel)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Use
for the relief of occasional sleeplessness
Otc - Do Not Use
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product avoid alcoholic drinks
Otc - Stop Use
Stop use and ask a doctor if
sleeplessness persist continuosly for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
Inactive Ingredients
FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water
Questions Or Comments?
1-800-632-6900
Principal Display Panel
COMPARE TO the active ingredient of
UNISOM® SLEEPGELS®**
NDC 30142-228-32
NDC 30142-228-40
NDC 30142-228-64
Kroger®
Sleep-Aid Softgels
MAXIMUM STRENGTH
Diphenhydramine HCI 50 mg
Nighttime Sleep Aid
Safe, Non-Habit Forming
32/40/64
LIQUID FILLED SOFTGELS one softgel per dose
actual size
**Unisom® SleepGels® is a registered trademark
of Chattem, Inc., Chattanooga, TN 37409.
Chattem, Inc., is not affiliated with The Kroger Co.
or this product.
* Please review the disclaimer below.