FDA Label for Zantac 360 Cool Mint

View Indications, Usage & Precautions

Zantac 360 Cool Mint Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, 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 Tablet)



Famotidine USP 20 mg


Purpose



Acid reducer


Uses



relieves heartburn associated with acid indigestion and sour stomach

prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages


Warnings



Allergy alert: Do not use if you are allergic to famotidine or other acid reducers


Do Not Use



■ if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

■ with other acid reducers


Ask A Doctor Before Use If You Have



had heartburn over 3 months. This may be a sign of a more serious condition.

■ heartburn with lightheadedness, sweating or dizziness

■ chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

■ frequent chest pain  

■ frequent wheezing, particularly with heartburn

■ unexplained weight loss

■ nausea or vomiting

■ stomach pain

■ kidney disease


Ask A Doctor Or Pharmacist Before Use If You Are



taking a prescription drug. Acid reducers may interact with certain prescription drugs.


Stop Use And Ask A Doctor If



your heartburn continues or worsens

■ you need to take this product for more than 14 days


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:

   ■ to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

   ■ to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn

   ■ do not use more than 2 tablets in 24 hours

■ children under 12 years: ask a doctor


Other Information



■ read the directions and warnings before use

■ keep the carton. It contains important information.

■ store at 20°-25°C (68°-77°F)

 protect from moisture

■ contains FD&C yellow no. 5 (tartrazine) as a color additive


Inactive Ingredients



artificial flavors, corn starch, FD&C blue no. 1 aluminum lake, FD&C yellow no. 5 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose, talc, titanium dioxide


Questions Or Comments?



call 1-866-844-2798 or visit www.zantacotc.com

Do not use if carton is open or if printed foil seal on bottle is broken or missing.

Keep carton as it contains important product information.


Principal Display Panel



Zantac
Famotidine Tablets USP 20 mg / Acid Reducer
360
Cool Mint
50 Tablets


* Please review the disclaimer below.