FAMOTIDINE TABLET, FILM COATED [MAGNO-HUMPHRIES, INC.]

FAMOTIDINE TABLET, FILM COATED [MAGNO-HUMPHRIES, INC.]
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NDC 54257-802-02
Set ID f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9
Category Human OTC Drug Label
Packager Magno-Humphries, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA206531
  • SPL UNCLASSIFIED SECTION


    Drug Facts

  • 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


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


    • 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
    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • unexplained weight loss
    • nausea or vomiting
    • stomach pain 
  • 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 (1-800-222-1222) right away.

  • 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

    • read the directions and warnings before use
    • store at 20° to 25°C (68° to 77°F)
    • protect from moisture

  • Inactive ingredients


    carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

  • Questions or comments?


    call 1-800-935-6737

    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


    JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

    Do not use if printed foil seal under bottle cap is open or torn.


    Distributed by:
    Magno-Humphries Labs
    Tigard, OR 97223, U.S.A.
    Visit our website: www.magno-humphries.com

    Made in India


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (100 Tablets, Container Label)

    MHL℗

    *Compare to the Active Ingredient
    of Maximum Strength Pepcid® AC

    MAXIMUM STRENGTH

    FAMOTIDINE
    TABLETS USP 20 mg

    ACID REDUCER  

    Just One Tablet Prevents & Relieves
    Heartburn Due to Acid Indigestion

    100 TABLETS

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (100 Tablets, Container Label)

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54257-802
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUND (Square shaped Biconvex) Size5mm
    FlavorImprint Code CC;59
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54257-802-02100 in 1 BOTTLE; Type 0: Not a Combination Product04/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653104/26/2016
    Labeler - Magno-Humphries, Inc. (063251433)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(54257-802) , MANUFACTURE(54257-802)

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