Label: FAMOTIDINE tablet, film coated

  • NDC Code(s): 58602-705-03, 58602-705-09, 58602-705-12, 58602-705-14, view more
    58602-705-15, 58602-705-19, 58602-705-34, 58602-705-39, 58602-705-40, 58602-705-44, 58602-705-84, 58602-705-88, 58602-705-93
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 23, 2020

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

  • SPL UNCLASSIFIED SECTION


    Drug Facts

  • Active ingredient (in each tablet)

    Famotidine USP 10 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.
    • 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 
    • kidney 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
    • 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 15 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
    • keep the carton. It contains important information.
    • 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 and titanium dioxide.

  • Questions or comments?


    call 1-855-274-4122


    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 carton is open or if printed foil seal under bottle cap is open or torn.

    Distributed by:
    AUROHEALTH LLC
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

    Made in India
    Code: TS/DRUGS/22/2009


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (90 Tablets Container Label)

    AUROHEALTH

    NDC 58602-705-19
    See New Warnings
    ORIGINAL STRENGTH
    Famotidine
    Tablets USP 10 mg
    Acid Reducer
    Just One Tablet!

    Prevents & Relieves Heartburn
    Due to Acid Indigestion
      

    90 Tablets   

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (90 Tablets Container Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (90 Tablets Container Carton Label)

    AUROHEALTH
    NDC 58602-705-19
    See New Warnings
    *Compare to the Active Ingredient
    of Original Strength Pepcid® AC
    ORIGINAL STRENGTH
    Famotidine
    Tablets USP 10 mg

    Acid Reducer
    Just One Tablet!


    Prevents & Relieves Heartburn
    Due to Acid Indigestion


    90 Tablets

    famotidine-fig2.jpg



  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg, Blister Carton 30 Tablets

    AUROHEALTH

    NDC 58602-705-09
    See New Warnings
    *Compare to the Active
    Ingredient of Original
    Strength Pepcid® AC
    ORIGINAL STRENGTH
    Famotidine
    Tablets USP
    10 mg

    Acid Reducer
    Just One Tablet!

    Prevents & Relieves Heartburn
    Due to Acid Indigestion

    30 Tablets
    famotidine-fig3.jpg




  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-705
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 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)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUND (biconvex) Size5mm
    FlavorImprint Code CC;58
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-705-151 in 1 CARTON04/26/2016
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-705-191 in 1 CARTON04/26/2016
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-705-841 in 1 CARTON05/13/2019
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-705-093 in 1 CARTON04/26/2016
    4NDC:58602-705-0310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:58602-705-124 in 1 CARTON04/26/2016
    5NDC:58602-705-0310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:58602-705-9390 in 1 BOTTLE; Type 0: Not a Combination Product04/26/2016
    7NDC:58602-705-141 in 1 CARTON12/21/2019
    750 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:58602-705-341 in 1 CARTON07/22/2020
    8200 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:58602-705-391 in 1 CARTON07/22/2020
    9365 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:58602-705-441 in 1 CARTON07/22/2020
    10400 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:58602-705-401 in 1 CARTON07/22/2020
    11500 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:58602-705-881 in 1 CARTON07/22/2020
    12750 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653104/26/2016
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-705) , MANUFACTURE(58602-705)