Label: GOOD SENSE HEARTBURN RELIEF- cimetidine tablet

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

Drug Label Information

Updated 01/13

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

  • Active ingredient (in each tablet)

    Cimetidine 200 mg

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  • Purpose

    Acid reducer

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  • 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 food and beverages
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  • Warnings

    Allergy alert: Do not use if you are allergic to cimetidine 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

    frequent chest pain
    frequent wheezing, particularly with heartburn
    unexplained weight loss
    nausea or vomiting
    stomach pain
    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

    Ask a doctor or pharmacist before use if you are

    taking

    theophylline (oral asthma medicine)
    warfarin (blood thinning medicine)
    phenytoin (seizure medicine)

    If you are not sure you are taking one of these medicines, talk to your doctor or pharmacist.

    Stop use and ask a doctor if

    your heartburn continues or worsens
    stomach pain continues
    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.

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  • 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 right before or any time up to 30 minutes before eating food or drinking beverages that cause heartburn
    do not take more than 2 tablets in 24 hours
    children under 12 years: ask a doctor
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  • Other information

    do not use if printed foil under cap is broken or missing
    store at 20°-25°C (68°-77°F)
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  • Inactive ingredients

    hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Consumer Information

    Cimetidine Tablets, 200 mg

    Acid Reducer

    For Heartburn

    Just one Cimetidine Tablet, 200 mg relieves and prevents heartburn and acid indigestion.

    This product reduces the production of stomach acid that can cause heartburn.

    In clinical studies, Cimetidine Tablets, 200 mg was significantly better than placebo tablets in relieving and preventing heartburn symptoms.

    And Cimetidine Tablets, 200 mg is approved to take before, during, or after a meal.

    Percent of Heartburn Episodes Relieved

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    Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken 30 Minutes Before a Meal

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    Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken at Time of Meal

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    Drug Interaction Warnings:

    This product affects some prescription medicines causing slightly higher levels of those medicines in the blood. Higher blood levels could lead to side effects in rare situations. If you currently take Theophylline(oral asthma medicine), Warfarin(blood thinning medicine) or Phenytoin(seizure medicine), consult your doctor before taking this product.

    Brand names of some medicines which contain one of these ingredients include:

    THEOPHYLLINE

    THEO-DUR® Theochron® Slo-Bid® Uniphyl® Theo-24®

    WARFARIN

    Coumadin®

    PHENYTOIN

    Dilantin®

    There may be other medicines that contain one of these ingredients. If in doubt about this or about possible effects of this product on any other medicines you are taking, talk to your doctor or pharmacist.

    For Prevention and Relief of Heartburn

    To prevent heartburn symptoms, take Cimetidine Tablet, 200 mg before your first bite or any time up to 30 minutes before eating food or drinking beverages that may cause heartburn.
    To relieve heartburn symptoms and for relief of acid indigestion and sour stomach, take Cimetidine Tablet, 200 mg at the first signs of discomfort.

    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

    READ THE LABEL

    Read the directions and warnings before taking this medication.

    Questions or comments? 1-800-719-9260

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  • PRINCIPAL DISPLAY PANEL

    Cimetidine 200mg Tablet

    Label
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  • INGREDIENTS AND APPEARANCE
    GOOD SENSE HEARTBURN RELIEF 
    cimetidine tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63629-4203(NDC:0113-0022)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CIMETIDINE (CIMETIDINE) CIMETIDINE 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    POVIDONES  
    SODIUM LAURYL SULFATE  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 13mm
    Flavor Imprint Code L022
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63629-4203-1 20 in 1 BOTTLE
    2 NDC:63629-4203-2 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075285 12/30/2002
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    Name Address ID/FEI Business Operations
    Bryant Ranch Prepack 171714327 REPACK(63629-4203), RELABEL(63629-4203)
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