RANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]

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RANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]
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NDC 55111-404-02, 55111-404-17, 55111-404-24, 55111-404-32, 55111-404-34, 55111-404-36, 55111-404-38, 55111-404-40, 55111-404-50, 55111-404-55, 55111-404-61, 55111-404-62, 55111-404-65, 55111-404-90
Set ID 00df8a42-296f-80dd-98af-ee8b30eb38cc
Category HUMAN OTC DRUG LABEL
Packager Dr. Reddy's Laboratories Limited
Generic Name
Product Class
Product Number
Application Number ANDA078192
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  • Active ingredient (in each tablet)

    Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

  • Purpose

    Acid reducer

  • Use(s)

    • 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
    • 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 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
      • 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 printed foil under bottle cap is open or torn
    • store at 20°-25°C (68°-77°F)
    • avoid excessive heat or humidity
    • protect from light
    • this product is sodium and sugar free
  • Inactive ingredients

    FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

  • Questions?

    Call 1-888-375-3784

    Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

  • SPL UNCLASSIFIED SECTION

    Tips for managing heartburn

    • Do not lie flat or bend over soon after eating

    • Do not eat late at night, or just before bedtime

    • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, and even some fruits and vegetables.

    • Eat slowly and do not eat beig meals

    • If you are overweight, lose weight

    • If you smoke, quit smoking

    • Raise the head of your bed

    • Wear loose fitting clothing around your stomach.

    Revised: 03/20

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    Container Label:

    Dr.Reddy's
    NDC 55111-404-34


    Maximum Strength
    Ranitidine
    Tablets USP,150 mg
    ACID REDUCER


    PREVENTS & RELIEVES
    HEARTBURN associated with acid indigestion
    and sour stomach

    24 Tablets(24 doses)

    container

  • PRINCIPAL DISPLAY PANEL

    Container Carton Label:

    Dr.Reddy's
    NDC 55111-404-34


    Compare to the active
    ingredient in Zantact 150® Tablets*


    Maximum Strength
    Ranitidine
    Tablets USP,150 mg
    ACID REDUCER


    PREVENTS & RELIEVES
    heartburn associated with acid indigestion
    and sour stomach

    24 Tablets(24 doses)


    containercarton

  • PRINCIPAL DISPLAY PANEL

    Blister Carton Label:

    Dr.Reddy's
    NDC 55111-404-24


    Maximum Strength
    Ranitidine
    Tablets USP,150 mg
    ACID REDUCER


    PREVENTS & RELIEVES
    HEARTBURN associated with acid indigestion
    and sour stomach

    24 Tablets(24 doses)

    blistercarton

  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-404
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ranitidine Hydrochloride (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code R150
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55111-404-341 in 1 CARTON12/02/2009
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55111-404-321 in 1 CARTON12/02/2009
    232 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55111-404-361 in 1 CARTON12/02/2009
    336 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:55111-404-501 in 1 CARTON12/02/2009
    450 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:55111-404-611 in 1 CARTON12/02/2009
    565 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:55111-404-552 in 1 CARTON01/05/2010
    665 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:55111-404-621 in 1 CARTON12/02/2009
    795 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:55111-404-902 in 1 CARTON12/02/2009
    895 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:55111-404-021 in 1 CARTON12/02/2009
    9200 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:55111-404-651 in 1 CARTON12/02/2009
    10220 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:55111-404-171 in 1 CARTON12/02/2009
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    12NDC:55111-404-243 in 1 CARTON12/02/2009
    128 in 1 BLISTER PACK; Type 0: Not a Combination Product
    13NDC:55111-404-384 in 1 CARTON12/02/2009
    138 in 1 BLISTER PACK; Type 0: Not a Combination Product
    14NDC:55111-404-401 in 1 BOTTLE12/02/2009
    1440 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07819212/02/2009
    Labeler - Dr. Reddy's Laboratories Limited (650562841)
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