FDA Label for Sleep Aid
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USE
- 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?
- PRINCIPAL DISPLAY PANEL
Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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 Tablet)
Doxylamine succinate 25 mg
Purpose
Nighttime sleep-aid
Use
- helps to reduce difficulty in falling asleep
Do Not Use
- in children under 12 years of age
- with any other product containing doxylamine
- unless you have time for a full night’s sleep
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
Ask A Doctor Or Pharmacist Before Use If You Are
taking
- sedatives or any other sleep-aid
- tranquilizers
- any other antihistamines
- any other drugs
When Using This Product
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- 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 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.
Directions
- adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
- children under 12 years of age: do not use
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- 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 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
Principal Display Panel
NDC 70677-1129-1
COMPARE TO UNISOM® SLEEPTABS®
ACTIVE INGREDIENT*
Foster & Thrive™
Sleep Aid
Doxylamine succinate tablets, 25 mg
NIGHTTIME SLEEP-AID
One tablet per dose
ACTUAL SIZE
32 TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
©2023 McKesson Corporation
Distributed by: McKesson Corp., via Strategic
Sourcing Services LLC., Memphis, TN 38141
Money Back Guarantee
www.fosterandthrive.com
*This product is not manufactured or distributed by Chattem,
Inc., owner of the registered trademark Unisom® SleepTabs®.
50844 ORG012338627 Rev. 04/23
* Please review the disclaimer below.