SUNMARK ACID REDUCER (RANITIDINE) TABLET, COATED [MCKESSON]

SUNMARK ACID REDUCER (RANITIDINE) TABLET, COATED [MCKESSON]
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NDC 49348-136-12, 49348-136-44
Set ID 009be4d3-555a-4f90-a8e8-a455b2524a30
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class
Product Number
Application Number ANDA076195
  • Active ingredient (in each tablet)

    Ranitidine 75 mg (as ranitidine hydrochloride 84 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
  • 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)
    do not chew tablet
    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 Regular Strength Ranitidine Tablets, 75 mg Acid Reducer

    (Please read all of this information before taking Ranitidine Tablets, 75 mg. Save this leaflet for future reference.)

    What are Ranitidine Tablets, 75 mg?

    Ranitidine Tablets, 75 mg contain 75 mg of ranitidine (as ranitidine hydrochloride, 84 mg), a medicine that doctors have prescribed more than 200 million times worldwide.
    Ranitidine Illustration

    Excellent Safety Record

    Ranitidine Tablets, 75 mg have been used safely and effectively for years as an over-the-counter medication.
    Ranitidine Tablets, 75 mg are sodium and sugar free.

    What symptoms do Ranitidine Tablets, 75 mg relieve and prevent?

    Ranitidine Tablets, 75 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 or 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 Ranitidine Tablets, 75 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).

    Do not chew tablet

    Ranitidine Tablets, 75 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 Ranitidine Tablets, 75 mg work?

    Ranitidine Tablets, 75 mg reduce the production of stomach acid. This is what makes Ranitidine Tablets, 75 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

    Additional 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

    Clinical studies prove Ranitidine Tablets, 75 mg are effective in relieving and preventing heartburn.

    In clinical studies, Ranitidine Tablets, 75 mg were significantly better than placebo pills.

    Percent of Heartburn Episodes Relieved

    Ranitidine Table 1

    Percent of Patients with Prevention or Reduction of Heartburn Symptoms

    Ranitidine Table 2

    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
    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

    : 87600 00 J1

  • Package/Label Principal Display Panel

    COMPARE TO ZANTAC 75® ACTIVE INGREDIENT

    Regular Strength

    Ranitidine Tablets, 75 mg

    acid reducer

    PREVENTS AND RELIEVES HEARTBURN associated with acid indigestion and sour stomach

    REGULAR STRENGTH

    Actual Size

    GLUTEN FREE

    30 TABLETS (30 DOSES)

    Sunmark acid reducer image
  • INGREDIENTS AND APPEARANCE
    SUNMARK ACID REDUCER 
    ranitidine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-136
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeHEXAGON (6 sided)Size8mm
    FlavorImprint Code RT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-136-441 in 1 CARTON05/23/2016
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49348-136-121 in 1 CARTON05/23/2016
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07619505/23/2016
    Labeler - Strategic Sourcing Services LLC (116956644)