Label: TAGAMET- cimetidine tablet

  • NDC Code(s): 63029-222-01, 63029-222-02, 63029-222-03, 63029-222-04, view more
    63029-222-05
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 27, 2019

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

  • SPL UNCLASSIFIED SECTION

    READ THE DIRECTIONS AND WARNINGS, INCLUDING THOSE PRINTED
    ON THE INSIDE OF THE CARTON, BEFORE TAKING THIS PRODUCT.

    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

    • your heartburn continues or worsens
    • stomach pain continues
    • 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 (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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

  • Questions? 

    Call toll-free 1-800-482-4394       tagamet.com

    Drug Interaction Warnings:

    Tagamet HB 200®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), Warafin (blood thinning medicine) or Phenytoin (seizure medicine), consult your doctor before taking Tagamet HB 200®.

    Brand names of some medicines which contain one of these ingredients include:

    THEOPHYLLINE THEO-DUR®
    Uniphyl®
    Theochron®
    Theo-24®
    Slo-Bid®
    WARFARINCoumadin®
    PHENYTOINDilantin®

      

    There may be other medicines that contain one of these ingredients. If in doubt about this or about possible effects of Tagamet HB 200® on any other medicines you are taking, talk to your doctor or pharmacist.

    Read the directions and warnings before taking this medication.

  • PRINCIPAL DISPLAY PANEL

    Tagamet® HB 200
    Cimetidine Tablets 200 mg
    Acid Reducer
    40
    TABLETS
    (40 DOSES)
    PRINCIPAL DISPLAY PANEL

Tagamet® HB 200
Cimetidine Tablets 200 mg
Acid Reducer
40
TABLETS
(40 DOSES)

    PRINCIPAL DISPLAY PANEL

Tagamet® HB 200
Cimetidine Tablets 200 mg
Acid Reducer
40
TABLETS
(40 DOSES)

  • INGREDIENTS AND APPEARANCE
    TAGAMET 
    cimetidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-222
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD) CIMETIDINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeDIAMONDSize13mm
    FlavorImprint Code TAGAMET;200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-222-021 in 1 BOX06/01/2012
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63029-222-011 in 1 BOX06/01/2012
    230 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:63029-222-031 in 1 BOX06/01/2012
    350 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:63029-222-044 in 1 BOX06/01/2019
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:63029-222-054 in 1 BOX06/01/2019
    59 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02023806/01/2012
    Labeler - Medtech Products Inc. (122715688)