Label: ACID REDUCER- ranitidine tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 8, 2016

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
    • 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 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)
    • 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

  • 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. Eating or drinking 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).

    • Do not chew tablet.

    • 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 make 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

    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.
    • 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

    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.

    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.

  • Consumer Information

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROJEN OR MISSING. 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:

  • PRINCIPAL DISPLAY PANEL

    Container Carton Label:

    containercarton

  • PRINCIPAL DISPLAY PANEL

    Container Label:

    label

  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    ranitidine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-869(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:69842-869-621 in 1 CARTON05/01/2010
    195 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07819205/01/2010
    Labeler - CVS HEALTH CORP (062312574)