Label: ZANTAC 360 COOL MINT- famotidine tablet, film coated

  • NDC Code(s): 41167-0364-0, 41167-0364-1
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 28, 2023

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  • 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

    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 TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0364
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorturquoise (Bluish-Green) Scoreno score
    ShapeSQUARE (Rounded Square Biconvex) Size4mm
    FlavorMINT (Cooling Mint Flavor Coating) Imprint Code Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0364-01 in 1 CARTON12/01/2022
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41167-0364-11 in 1 CARTON12/01/2022
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653112/01/2022
    Labeler - Chattem, Inc. (003336013)
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