Label: CIMETIDINE ACID REDUCER- cimetidine tablet, film coated

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

Drug Label Information

Updated May 20, 2021

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  • Active ingredient (in each tablet)

    Cimetidine 200 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 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
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    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 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 right before or any time up to 30minutes 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 20°-25°C (68°-77°F)
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Tagamet HB® 200 active ingredient

    Cimetidine 200

    CIMETIDINE TABLETS USP, 200 mg / ACID REDUCER

    Just one tablet relieves & prevents heartburn & acid indigestion

    Take before, during or after a meal

    60 TABLETS (60 DOSES)

    ACTUAL SIZE

    Cimetidine 200 Carton Image 1
    Cimetidine 200 Carton Image 2
  • INGREDIENTS AND APPEARANCE
    CIMETIDINE  ACID REDUCER
    cimetidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD) CIMETIDINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code L022
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0022-721 in 1 CARTON04/14/2010
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07528503/27/2001
    Labeler - Walgreen Company (008965063)
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