FDA Label for Nighttime Sleep-aid
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPSULE)
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- 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?
- OTHER
- 64'S COUNT
Nighttime Sleep-aid Product Label
The following document was submitted to the FDA by the labeler of this product Discount Drug Mart, 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 Capsule)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Uses
■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep
Warnings
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
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ difficulty in urination due to 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 ■ be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
sleeplessness persists continuosly for more than 2 weeks, consult your doctor. 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 (1-800-222-1222) right away.
Directions
■
Adults and children 12 years of age and over:One softgel (50 mg) at bedtime if needed, or as directed by a doctor.
■ swallow whole; do not crush, chew, or dissolve
Other Information
■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F).
■ protect from light
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution
Questions Or Comments?
call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
Other
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
†This product is not manufactured or distributed by the owners of Unisom® SleepGels®.
MADE IN INDIA
Distributed by: Discount Drug Mart
211 Commerce Drive, Medina, Ohio 44256
www.discount-drugmart.com
SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE
WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON
FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO:
DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256
T00194R0124
Mfg. Lic. No.: TN00002123
L0000784
R0224
Lot No.:
Exp. Date:
64'S Count
NDC 53943-485-18
discount
drug
mart
food market
AN EMPLOYEE OWNERSHIP COMPANY
Nighttime Sleep-aid
Diphenhydramine HCl Capsules, USP 50 mg
• Fall asleep fast • Sleep soundly
• Safe, non-habit forming
One Softgel Per Dose
†Compare to the active ingredient in Unisom® SleepGels®
64 SOFTGELS**
**Liquid-filled capsules
* Please review the disclaimer below.