Label: TAGAMET- cimetidine tablet

  • NDC Code(s): 52183-223-30
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 20, 2023

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  • SPL UNCLASSIFIED SECTION

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    Drug Facts

  • Active ingredient (in each tablet)

    Cimetidine 200mg

  • 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 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
    • kidney disease
    • liver disease

    Ask a doctor or pharmacist before use if

    you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

    Stop use and ask a doctor if

    • you need to take this product for more than 14 days
    • stomach pain continues
    • your heartburn continues or worsens

    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 (1-800-222-1222) right away.

  • Directions

    • adults and children 12 years and older:
      ▪ 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
  • Other information

    store at 15-30ºC (59-86ºF)

  • Inactive ingredients

    cellulose, corn starch, FD&C Blue #1 Lake, flavor, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

  • Questions?

    Call toll-free 1-800-482-4394 weekdays

  • PRINCIPAL DISPLAY PANEL

    Tagamet® HB 200
    Cimetidine Tablets 200 mg
    Acid Reducer

    30 tablets (30 doses)

    PRINCIPAL DISPLAY PANEL Tagamet® HB 200 Cimetidine Tablets 200 mg Acid Reducer Icy Cool Mint Flavor 30 tablets (30 doses)

  • INGREDIENTS AND APPEARANCE
    TAGAMET 
    cimetidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-223
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD) CIMETIDINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeDIAMONDSize13mm
    FlavorPEPPERMINTImprint Code TAGAMET;200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-223-303 in 1 BOX02/01/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02023802/01/2023
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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