WAL-ZAN TABLET [WALGREENS COMPANY]

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WAL-ZAN TABLET [WALGREENS COMPANY]
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NDC 0363-1029-03, 0363-1029-08
Set ID 22c06ca2-fd55-9feb-c153-adc66c263f90
Category HUMAN OTC DRUG LABEL
Packager Walgreens Company
Generic Name
Product Class
Product Number
Application Number ANDA075167
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  • Drug Facts Active ingredient (in each tablet)

    Ranitidine 75 mg (as ranitidine hydrochloride, USP 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 broken or torn
    • store at 20°C to 25°C (68°F to 77°F)
    • avoid excessive heat or humidity
    • this product is sodium and sugar free

  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide and vanillin.

  • Questions or comments?

    1-800-706-5575

    Bottle contains desiccant.

    Walgreens Pharmacist Recommended

    Walgreens Pharmacist Survey

    †† This product is not manufactured or distributed by Chattem [A Sanofi Company], distributor of Zantac 75 Tablets. Zantac 75 is a registered trademark of Chattem [A Sanofi Company].

  • Principal Display Panel

    Walgreens

    Regular Strength

    Wal-Zan® 75mg

    Ranitidine Tablets, USP

    75 mg/ Acid Reducer

    80 Tablets

    NDC: 0363-1029-08

    wal-zan-75mg

  • INGREDIENTS AND APPEARANCE
    WAL-ZAN 
    wal-zan tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1029
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    VANILLIN (UNII: CHI530446X)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOCTAGON (8 sided)Size8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1029-031 in 1 CARTON07/31/2015
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-1029-081 in 1 CARTON07/31/2015
    280 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07516707/31/2015
    Labeler - Walgreens Company (008965063)
    Registrant - Apotex Inc. (209429182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accucaps Industries Limited248441727analysis(0363-1029) , manufacture(0363-1029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accucaps Industries Limited Strathroy243944050analysis(0363-1029) , manufacture(0363-1029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Legacy Pharmaceutical Packaging143213275pack(0363-1029)
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