FDA Label for Nighttime Sleep Aid
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- 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?
- PRINCIPAL DISPLAY PANEL
Nighttime Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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 Tablet)
Doxylamine succinate 25 mg
Purpose
Nighttime sleep-aid
Use
helps to reduce difficulty in falling asleep
Ask A Doctor Before Use If You Have
- glaucoma
- a breathing problem such as asthma, 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 any other drugs.
When Using This Product
- avoid alcoholic beverages
- take only at bedtime
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a 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 and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
- children under 12 years: do not use
Other Information
- store at controlled room temperature 20°-25°C (68°-77°F)
- see end flap for expiration date and lot number
Inactive Ingredients
dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal Display Panel
♥︎CVSHealth™
Compare to the active ingredient
in Unisom® SleepTabs®*
Tablets
Nighttime
Sleep-Aid
DOXYLAMINE SUCCINATE TABLETS, 25 mg
Nighttime sleep-aid
Helps to reduce difficulty in falling asleep
Actual Bottle Size on Side Panel
2 x 96 TABLETS
One tablet per dose
192 TABLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
50844 REV0718A38646
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP-CVS
✓CVS Quality
Money Back Guarantee
* Please review the disclaimer below.