Label: RANITIDINE tablet, coated

  • NDC Code(s): 55111-404-02, 55111-404-17, 55111-404-24, 55111-404-32, view more
    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
  • Packager: Dr. Reddy's Laboratories Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 2, 2019

If you are a consumer or patient please visit this version.

  • 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 interactwith 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

    Revised: 0419

  • Consumer Information

    What you should know about

    MAXIMUM STRENGTH

    Ranitidine Tablets USP, 150 mg

    (Please read all of this information before taking MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg. Save this leaflet for future reference.)

    What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

    • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg contains 150 mg of ranitidine (as ranitidine hydrochloride USP, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

    Excellent Safety Record

    • The ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg has been taken safely with many frequently prescribed medications.
    • MAXIMUM STRENGTH Ranitidne Tablets USP, 150 mg are sodium and sugar free.

    What symptoms does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent?

    • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent heartburn associated with acid Indigestion and sour stomach.
    • Certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion and sour stomach. It is normal to the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort.

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    How should I take MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

    • 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.

    • This medicine can be used up to twice daily (up to 2 tablets in 24 hours).

    • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg should not be given to children under 12 years old unless directed by a doctor.

    • Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers.

    How does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg work?

    • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg reduce the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

    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, even some fruits and vegetables
    • Eat slowly and do not eat big 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

    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

    When should I see a doctor?

    • Ask a doctor before use if you have

    • had heartburn over 3 months. This may be a sign of a more serious condition.
    • heartbrun 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 ifyou are

    • taking a prescription drug. Acid reducersmay interact with certain prescription drugs.

    • 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 (1-800-222-1222).

    Questions? Call 1-888-375-3784

    BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn.

    BLISTERS: Do not use if the individual blister unit is open or torn.

    Revised: 0419

  • PRINCIPAL DISPLAY PANEL

    SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION. IMPORTANT:

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

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    Container Label:

  • Carton Label

    Dr.Reddy's
    NDC 55111-404-61


    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

    65 Tablets(65 doses)


    carton

  • Bottle

    Dr.Reddy's
    NDC 55111-404-61


    Maximum Strength
    Ranitidine
    Tablets USP,150 mg
    ACID REDUCER


    PREVENTS & RELIEVES
    heartburn associated with acid indigestion
    and sour stomach

    65 Tablets(65 doses)


    bottle

  • PRINCIPAL DISPLAY PANEL

    Blister Carton Label:

  • 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)