Label: ZANTAC 150- ranitidine tablet

  • NDC Code(s): 50269-220-25
  • Packager: JC World Bell Wholesale Co., Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 18, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ​Drug Facts

  • ​Active ingredient (in each tablet)

    Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

    ​Purpose

    Acid reducer

  • ​Uses

    • relieves heartburn associated with acid indigestion and sour stomach
    • relieves heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and  beverages
  • ​Warnings

    ​Allergy alert:​ Do not use if you are allergic to ranitidine 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
    • if you have kidney disease, except under the advice and supervision of a doctor.

    Ask a doctor before use if you have

    • had hertburn 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

    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.

  • Directions

    • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a glass of water
    • to prevent symptoms, swallow 1 tablet with a glass of water ​30 to 60 minutes before​ eating food or drinking beverages that cause heartburn
    • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
    • children under 12 years:  ask a doctor
  • ​Other information

    • do not use if individual foil pouch is open or torn
    • avoid excessive heat or humidity
    • store at 20 ​0-25 ​0​C (68 ​0​-77 ​0​F)
    • this product is sodium and sugar free
  • ​Inactive ingredients

    hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide,titanium dioxide, triacetin.

  • ​Questions?

    call 1-888-285-9159 (English/Spanish)M-F, 8:30-5 EST, or visit www.zantacotc.com for ​Tips for Managing Heartburn

  • ​Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ZANTAC 150 
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-220
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColororangeScoreno score
    ShapePENTAGON (5 sided)Size7mm
    FlavorImprint Code Z;150
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50269-220-2525 in 1 BOX07/29/2016
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02169807/29/2016
    Labeler - JC World Bell Wholesale Co., Inc. (805257581)