Label: ACID REDUCER- ranitidine tablet, film coated

  • NDC Code(s): 59779-540-01, 59779-540-02, 59779-540-09, 59779-540-82
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 13, 2016

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

  • 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
    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
    if you have kidney disease, except under the advice and supervision of 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.
    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 (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
    this product is sodium and sugar free
  • Inactive ingredients

    D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin

    Questions or comments?

    1-800-719-9260

  • Consumer Information

    What you should know about

    MAXIMUM STRENGTH

    Ranitidine Tablets, 150 mg

    Acid Reducer

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

    What are MAXIMUM STRENGTH Ranitidine Tablets, 150 mg?

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

    Excellent Safety Record

    The ingredient in MAXIMUM STRENGTH Ranitidine Tablets, 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, 150 mg has been taken safely with many frequently prescribed medications.
    Image 1
    MAXIMUM STRENGTH Ranitidine Tablets, 150 mg are sodium and sugar free.

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

    MAXIMUM STRENGTH Ranitidine Tablets, 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 for 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.

    How should I take MAXIMUM STRENGTH Ranitidine Tablets, 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 (do not take more than 2 tablets in 24 hours).
    MAXIMUM STRENGTH Ranitidine Tablets, 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 do MAXIMUM STRENGTH Ranitidine Tablets, 150 mg work?

    MAXIMUM STRENGTH Ranitidine Tablets, 150 mg reduce the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets, 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

    When should I see a doctor?

    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 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 healthcare 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 or comments? 1-800-719-9260

    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.

    Distributed by

    Perrigo®

    Allegan, MI 49010

    : 852B4 00 J2

  • Package/Label Principal Display Panel

    Compare to the active ingredient in Zantac 150®

    MAXIMUM STRENGTH

    RANITIDINE TABLETS, 150 mg

    Acid Reducer

    PREVENTS & RELIEVES HEARTBURN associated with acid indigestion & sour stomach

    Actual Size

    24 TABLETS (24 Doses)

    CVS Health Acid Reducer image
  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    ranitidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-540
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBROWN (Beige) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code L852
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-540-021 in 1 CARTON09/14/2015
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59779-540-091 in 1 CARTON09/23/2015
    265 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59779-540-011 in 1 CARTON09/14/2015
    395 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:59779-540-821 in 1 CARTON09/18/2015
    4200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09142909/14/2015
    Labeler - CVS Pharmacy (062312574)