Label: FAMOTIDINE tablet, film coated

  • NDC Code(s): 58602-706-14, 58602-706-15, 58602-706-16, 58602-706-18, view more
    58602-706-21, 58602-706-34, 58602-706-39, 58602-706-40, 58602-706-44, 58602-706-47, 58602-706-50, 58602-706-53, 58602-706-54, 58602-706-56, 58602-706-60, 58602-706-62, 58602-706-79, 58602-706-88, 58602-706-94
  • 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 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.
    • 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 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
    • 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, titanium dioxide and yellow iron oxide.

  • 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 -20 mg (50 Tablets, Container Label)

    AUROHEALTH
    NDC 58602-706-14
    See New Warnings
    MAXIMUM STRENGTH
    Famotidine
    Tablets USP 20 mg

    Acid Reducer
    Just One Tablet!

    Prevents & Relieves Heartburn
    Due to Acid Indigestion

    50 Tablets

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Carton Label)


    AUROHEALTH

    NDC 58602-706-14
    *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

    50 Tabletsfamotidine-20mg-fig2.jpg









  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg Blister Carton 25 Tablets


    AUROHEALTH

    NDC 58602-706-62
    *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

    25 Tablets

    famotidine-20mg-fig3.jpg

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-706
    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:58602-706-531 in 1 CARTON04/26/2016
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-706-561 in 1 CARTON04/26/2016
    235 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-706-141 in 1 CARTON04/26/2016
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-706-161 in 1 CARTON04/26/2016
    465 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-706-541 in 1 CARTON04/26/2016
    570 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:58602-706-471 in 1 CARTON04/26/2016
    675 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:58602-706-181 in 1 CARTON04/26/2016
    780 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:58602-706-501 in 1 CARTON04/26/2016
    885 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:58602-706-211 in 1 CARTON04/26/2016
    9100 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:58602-706-625 in 1 CARTON04/26/2016
    10NDC:58602-706-605 in 1 BLISTER PACK; Type 0: Not a Combination Product
    11NDC:58602-706-94100 in 1 BOTTLE; Type 0: Not a Combination Product04/26/2016
    12NDC:58602-706-791 in 1 CARTON04/26/2016
    128 in 1 BLISTER PACK; Type 0: Not a Combination Product
    13NDC:58602-706-152 in 1 CARTON02/24/2020
    138 in 1 BLISTER PACK; Type 0: Not a Combination Product
    14NDC:58602-706-341 in 1 CARTON07/22/2020
    14200 in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:58602-706-391 in 1 CARTON07/22/2020
    15365 in 1 BOTTLE; Type 0: Not a Combination Product
    16NDC:58602-706-441 in 1 CARTON07/22/2020
    16400 in 1 BOTTLE; Type 0: Not a Combination Product
    17NDC:58602-706-401 in 1 CARTON07/22/2020
    17500 in 1 BOTTLE; Type 0: Not a Combination Product
    18NDC:58602-706-88750 in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    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(58602-706) , MANUFACTURE(58602-706)