FDA Label for Sleep Aid

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH CAPLET)
PURPOSE
USES
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?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Ulai Health Llc. 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 Caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Uses

helps reduce difficulty falling asleep

Do Not Use

in children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other antihistamines

Ask A Doctor Before Use If You Have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
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
use caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of 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 and over	take 2 caplets at bedtime if needed, or as directed by your doctor

Other Information

each caplet contains: calcium 15 mg
store at 20-25^oC (68-77^oF)

Inactive Ingredients

colloidal silicon dioxide, corn startch, FD&C blue #1, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Package Label.Principal Display Panel

PHARBEST

NDC 73057-358-06

Manufactured in the USA

Safe, Non-habit forming

Sleep Aid

*Compare to the active ingredient in Sominex^®