FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]

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  • FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]

FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]
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NDC 51660-036-26
Set ID 653c165e-3e22-4796-b170-cc87547574c4
Category HUMAN OTC DRUG LABEL
Packager Ohm Laboratories Inc.
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.
    •
    TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. (for blister carton)
    •
    TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for bottle carton/label)
    •
    TAMPER EVIDENT: DO NOT USE IF THE PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for SAL/extended label)
  • 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.

    See end panel for batch number and expiration date. (for carton only)

    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

    †Compare to the active ingredient of Maximum Strength Pepcid AC®.

    NDC 51660-036-26

    ohm®

    MAXIMUM STRENGTH

    Acid Controller

    Famotidine Tablets, USP 20 mg

    Acid Reducer

    Just One Tablet

    Prevents & Relieves Heartburn

    Due to Acid Indigestion

    25 TABLETS

    Distributed by: Ohm Laboratories Inc.

    5142565/R0517

    20 mg 25 ct

    25's Blister Carton

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE - ACID CONTROLLER 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-036
    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 (TYPE H) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    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:51660-036-2625 in 1 BOTTLE; Type 0: Not a Combination Product05/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09028305/31/2017
    Labeler - Ohm Laboratories Inc. (184769029)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(51660-036)
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