FDA Label for Maximum Strength Nighttime Sleep Aid
View Indications, Usage & Precautions
Maximum Strength Nighttime Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, 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
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
Other Information
- Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol, titanium dioxide
Questions Or Comments?
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MAXIMUM STRENGTH Nighttime Sleep-Aid
200 SOFTGELS
*Compare to the active ingredient in Unisom® SleepGels® Nighttime Sleep-Aid
* Please review the disclaimer below.