Label: ZANTAC 360- famotidine tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 13, 2022

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  • SPL UNCLASSIFIED SECTION

    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
    • store at 20-25°C (68-77°F)
    • protect from moisture
  • Inactive ingredients

    carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide

  • Questions or Comments?

    call 1-800-633-1610 or visit www.zantacotc.com

  • SPL UNCLASSIFIED SECTION

    Product Repackaged and Distributed
    with permission of manufacturer by:
    Select Corporation Carrollton, TX 75007

  • PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack

    NEW FORMULA
    MAXIMUM STRENGTH
    See New Warnings

    Zantac
    360°™
    Famotidine Tablets USP 20 mg/Acid Reducer

    JUST ONE TABLET
    PREVENTS
    & RELIEVES
    HEARTBURN
    DUE TO ACID
    INDIGESTION

    1 TABLET
    Actual Size

    2111926095.A

    Principal Display Panel - 1 Tablet Pouch Blister Pack
  • INGREDIENTS AND APPEARANCE
    ZANTAC 360 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-926(NDC:41167-0360)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    famotidine (UNII: 5QZO15J2Z8) (famotidine - UNII:5QZO15J2Z8) famotidine10 mg
    Inactive Ingredients
    Ingredient NameStrength
    carnauba wax (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    ferric oxide red (UNII: 1K09F3G675)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    hydroxypropyl cellulose (1600000 WAMW) (UNII: RFW2ET671P)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    hypromellose 2910 (5 mpa.s) (UNII: R75537T0T4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUND (biconvex) Size5mm
    FlavorImprint Code CC;58
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-926-041 in 1 BLISTER PACK04/12/2021
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653104/12/2021
    Labeler - Select Corporation (053805599)
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