FDA Label for Good Sense Sleep Time

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH SOFTGEL)
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

Good Sense Sleep Time Product Label

The following document was submitted to the FDA by the labeler of this product L. Perrigo 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.

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

•for the relief of occasional sleeplessness
•reduces time to fall asleep if you have difficulty falling asleep

Do Not Use

•for children under 12 years of age
•with any other product containing diphenhydramine, even one used on skin
•with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
•with other Nighttime products

Ask A Doctor Before Use If You Have

•a breathing problem such as emphysema or chronic bronchitis
•glaucoma
•difficulty in urination due to an enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

•avoid alcoholic beverages
•drowsiness will occur
•do not drive a motor vehicle or operate 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.

Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

•take only one dose per day (24 hours) – see Overdose warning



2 softgels at bedtime if needed or as directed by a doctor

do not use

Other Information

•store at 20-25°C (68-77°F)
•avoid excessive heat above 40°C (104°F)
•protect from light

Inactive Ingredients

edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

Non-Habit Forming

Sleep Time

Nighttime Sleep-Aid

Actual Size