FDA Label for Nighttime Sleep Aid Maximum Strength

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT (IN EACH SOFTGEL)
PURPOSE
USES
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL

Nighttime Sleep Aid Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Equate (walmart Stores, 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.

Other

Drug Facts

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

for the 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

Directions

adults and children 12 years of age and over: take 1 softgel (50 mg) at bedtime if needed, or as directed by adoctor

Other Information

store at 15°-30°C (59°-86°F)

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments?

Call toll free 1-888-287-1915

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Nighttime Sleep-Aid
Maximum Strength

Diphenhydramine HCl, 50 mg

Compare to Unisom® SleepGels® Active Ingredient*

32 Softgels

NDC 49035-237-16

Distributed by: Wal-Mart Stores, Inc.
Bentonville, AR 72716

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

Nighttime Sleep-Aid

Maximum Strength