Label: RANITIDINE- ranitidine hydrochloride tablet 

  • Label RSS
  • NDC Code(s): 53329-695-68
  • Packager: Medline Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

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)

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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 foods and beverages
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  • 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

    • 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

    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).

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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 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
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  • OTHER INFORMATION

    • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
    • store at 20° - 25° C (68° - 77° F)
    • avoid excessive heat or humidity
    • this product is sodium and sugar free
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  • INACTIVE INGREDIENTS

    Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

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  • QUESTIONS?

    Call 1-800-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST

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  • PRINCIPAL DISPLAY PANEL

    MEDLINE

    NDC 53329-695-68

    Compare to the active ingredient of Zantac 150®

    Maximum Strength

    RANITIDINE TABLETS, USP 150 mg

    ACID REDUCER

    Prevents & Relieves

    Heartburn Associated with Acid Indigestion & Sour Stomach

    150 mg

    24 TABLETS

    Distributed by: Medline Industries, Inc.

    5099014/1012

    24's blister carton label
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  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53329-695
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
    Inactive Ingredients
    Ingredient Name Strength
    COLLOIDAL SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white (Off-White to Pale Yellow) Score no score
    Shape OVAL Size 7mm
    Flavor Imprint Code 9R
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-695-68 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA200536 03/30/2012
    Labeler - Medline Industries, Inc. (025460908)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Shasun Pharmaceuticals Limited 915786829 manufacture(53329-695)
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