ZANTAC 360 COOL MINT- famotidine tablet, film coated

Zantac 360 Cool Mint by

Drug Labeling and Warnings

Zantac 360 Cool Mint by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Zantac 360° Cool Mint Tablets Famotidine 20 mg

Drug Facts

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

INGREDIENTS AND APPEARANCE

ZANTAC 360 COOL MINT 
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0364
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	turquoise (Bluish-Green)	Score	no score
Shape	SQUARE (Rounded Square Biconvex)	Size	4mm
Flavor	MINT (Cooling Mint Flavor Coating)	Imprint Code	Z
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0364-0	1 in 1 CARTON	12/01/2022
1		25 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41167-0364-1	1 in 1 CARTON	12/01/2022
2		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206531	12/01/2022

Labeler - Chattem, Inc. (003336013)