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

  • NDC Code(s): 66715-9758-2, 66715-9758-5
  • Packager: Lil' Drug Store Products, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 29, 2024

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  • Drug Facts

  • Active Ingredient

    Active ingredient (in each tablet)
    Famotidine USP 20 mg

  • Purpose

    Purpose

    Acid reducer

  • Uses

    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 foods and beverages
  • Warnings

    Alergy alert

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

    Do not use

    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

    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

    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

    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 healthcare 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

    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

    Other information

    • read the directions and warnings before use
    • keep the carton. It contains important information.
    • store at 20º-25ºC (68º-77ºF)
    • protect from moisture
  • Inactive ingredients

    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?

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

  • SPL UNCLASSIFIED SECTION

    Product manufactured for:
    Chattem, Inc., a Sanofi Company
    P.O. Box 2219
    Chattanooga, TN 37409-0219
    ©2021 Made in India

    Product repackaged and distributed by:
    Lil' Drug Store Products, Inc.
    9300 Earhart Lane SW, Cedar Rapids, IA 52404
    1-877-507-6516 (M-F 8AM-4:30PM CST)
    www.lildrugstore.com 97585C-US-04-21

  • PDP/Package

    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

    [tablet image]

    Actual Size

    5 Tablets

    (5 Doses)

    [Lil' Drug Store logo]

    PDP

  • Zantac 360°™, Lil' Drug Store ® - PDP/Package

    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

    [tablet image]

    Actual Size

    2 Tablets

    (2 Doses)

    [Lil' Drug Store logo]

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    ZANTAC 360 
    famotidine tablet, film-coated tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9758
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeSQUARE (Rounded edges; biconvex) Size5mm
    FlavorImprint Code CC;59
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9758-51 in 1 CARTON09/20/2021
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:66715-9758-21 in 1 CARTON01/05/2023
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653109/20/2021
    Labeler - Lil' Drug Store Products, Inc (093103646)
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