FAMOTIDINE TABLET, FILM COATED [HEB]

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  • FAMOTIDINE TABLET, FILM COATED [HEB]

FAMOTIDINE TABLET, FILM COATED [HEB]
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NDC 37808-036-26, 37808-036-50
Set ID 4c077059-3074-4cd9-88e8-aef26af82953
Category HUMAN OTC DRUG LABEL
Packager HEB
Generic Name
Product Class
Product Number
Application Number ANDA090283
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  • ACTIVE INGREDIENT (IN EACH TABLET)

    Famotidine, USP 20 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 food and beverages
  • WARNINGS

    Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

    Do not use

    •
    with other acid reducers
    •
    if you have kidney disease, except under the advice and supervision of a doctor
    •
    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.

    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).

  • DIRECTIONS

    •
    adults and children 12 years and over:
    •
    to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    •
    to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
    •
    do not use more than 2 tablets in 24 hours
    •
    children under 12 years: ask a doctor
  • OTHER INFORMATION

    •
    store at 20° to 25°C (68° to 77°F)
    •
    protect from moisture
    •
    read the directions and warnings before use
    •
    keep the carton. It contains important information.
  • INACTIVE INGREDIENTS

    Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

  • QUESTIONS?

    Call 1-800-406-7984

  • PATIENT INFORMATION

    •
    JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
    •
    TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.

    Tips for Managing Heartburn

    •
    Do not lie flat or bend over after eating
    •
    Do not wear tight-fitting clothing around the stomach
    •
    Do not eat before bedtime
    •
    Raise the head of your bed
    •
    Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
    •
    Eat slowly and avoid big meals
    •
    If overweight, lose weight
    •
    Quit smoking
  • PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton

    Compare to Maximum Strength Pepcid AC®
    active ingredient†

    NDC 37808-036-50

    H-E-B®

    Maximum Strength
    Acid Controller
    Famotidine Tablets, USP 20 mg

    Acid Reducer

    Just One Tablet
    Prevents & Relieves Heartburn
    Due to Acid Indigestion

    actual size

    50 TABLETS

    PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-036-261 in 1 CARTON04/09/2014
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:37808-036-501 in 1 CARTON04/09/2014
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09028304/09/2014
    Labeler - HEB (007924756)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(37808-036)
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