ZANTAC 75 REGULAR STRENGTH (RANITIDINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]

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ZANTAC 75 REGULAR STRENGTH (RANITIDINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]
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NDC 41167-0300-0, 41167-0300-1, 41167-0300-2, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8
Set ID 543ee375-8faf-4f60-9a30-922b58168622
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number NDA020520
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  • SPL UNCLASSIFIED SECTION

    Zantac 75®

    Drug Facts

  • Active ingredient (in each tablet)

    Ranitidine 75 mg (as ranitidine hydrochloride 84 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 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

    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

    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)
      ▪ do not chew tablet
    • children under 12 years: ask a doctor
  • Other information

    • do not use if printed foil under bottle cap is open or torn
    • store at 20-25°C (68-77°F)
    • avoid excessive heat or humidity
    • this product is sodium and sugar free
  • Inactive ingredients

    hypromellose, magnesium stearate, microcrystalline cellulose, iron oxide, titanium dioxide, triacetin

  • Questions?

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

    Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

  • PRINCIPAL DISPLAY PANEL

    Regular Strength
    Zantac
    75
    Ranitidine 75 mg/ Acid reducer
    80 TABLETS (80 DOSES)

    PRINCIPAL DISPLAY PANEL Regular Strength Zantac 75 Ranitidine 75 mg/ Acid reducer 80 TABLETS (80 DOSES)

  • INGREDIENTS AND APPEARANCE
    ZANTAC 75  REGULAR STRENGTH
    ranitidine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0300
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorPINK (dark pink) Scoreno score
    ShapePENTAGON (5 SIDED)Size3mm
    FlavorImprint Code Z;75
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0300-21 in 1 CARTON10/12/2018
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-0300-31 in 1 CARTON08/17/2018
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-0300-53 in 1 CARTON08/17/2018
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:41167-0300-61 in 1 CARTON04/03/2018
    460 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:41167-0300-71 in 1 CARTON04/03/2018
    580 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:41167-0300-01 in 1 CARTON11/26/2018
    61 in 1 POUCH; Type 0: Not a Combination Product
    7NDC:41167-0300-11 in 1 CARTON04/03/2018
    72 in 1 POUCH; Type 0: Not a Combination Product
    8NDC:41167-0300-8100 in 1 CONTAINER04/03/2018
    81 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02052004/03/2018
    Labeler - Chattem, Inc. (003336013)
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