Label: ACID REDUCER- cimetidine tablet, film coated

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

Drug Label Information

Updated January 7, 2020

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

  • 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
    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 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 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?

    1-800-632-6900

  • Consumer Information

    Cimetidine Tablets, 200 mg

    Acid Reducer

    For Heartburn

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

    Percent of Heartburn Episodes Relieved

    Chart Image

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

    Chart Image

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

    Chart Image

    Drug Interaction Warnings:

    Cimetidine Tablets, 200 mg 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 Cimetidine Tablets, 200 mg on any other medicines you are taking, talk to your doctor or pharmacist.

    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 directions and warnings before taking this medication.

    Questions or Comments?

    1-800-719-9260

    Distributed By

    Perrigo®

    Allegan, MI 49010

    Rev 08/19

    02200 00 J5

  • Principal Display Panel

    COMPARE TO the active ingredient of TAGAMET® HB 200

    See side panel

    OUR PHARMACIST RECOMMENDED

    Cimetidine Tablets, 200 mg

    Acid Reducer

    One Tablet Dose

    Just One Tablet Relieves & Prevents Heartburn & Acid Indigestion

    Take Any Time you need it:

    Before Meal

    During Meal

    After Meal

    READ AND RETAIN THE IMPORTANT INFORMATION AND DRUG INTERACTION WARNINGS PRINTED ON THE PRODUCT INFORMATION SHEET

    actual size

    30 TABLETS (30 DOSES)

    acid reducer image
  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    cimetidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-323
    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:30142-323-391 in 1 CARTON10/21/2015
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07528510/21/2015
    Labeler - Kroger Company (006999528)