FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]

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FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]
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NDC 55111-118-12, 55111-118-18, 55111-118-24, 55111-118-30, 55111-118-35, 55111-118-60, 55111-118-79, 55111-118-81, 55111-118-90, 55111-396-01, 55111-396-08, 55111-396-16, 55111-396-32, 55111-396-35, 55111-396-44, 55111-396-50
Set ID 387088a6-8eaa-fc49-8050-a546d0f0fd32
Category HUMAN OTC DRUG LABEL
Packager Dr.Reddys Laboratories Limited
Generic Name
Product Class
Product Number
Application Number ANDA077367
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  • Active ingredient (in each tablet)

    Famotidine USP, 10 mg/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 right away. (1-800-222-1222)

  • Directions

    • For Famotidine 10 mg:
    • 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
    • For Famotidine 20 mg:
    • 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°-25°C (68°-77°F)
    • protect from moisture and light
  • Inactive ingredients

    colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, synthetic red iron oxide (only in 10 mg), talc and titanium dioxide

  • Questions or comments?

    call 1-888-375-3784

  • SPL UNCLASSIFIED SECTION

    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

    Famotidine 10 mg

    Container Label

    container10mg

  • PRINCIPAL DISPLAY PANEL

    Container Carton Label

    carton10mg

  • PRINCIPAL DISPLAY PANEL

    Famotidine 20 mg

    Container Label

    container20mg

  • PRINCIPAL DISPLAY PANEL

    Container Carton Label

    carton20mg

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code C;118
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55111-118-301 in 1 CARTON09/30/2006
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55111-118-401 in 1 CARTON10/01/2020
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55111-118-601 in 1 CARTON09/30/2006
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:55111-118-901 in 1 CARTON09/30/2006
    490 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:55111-118-041 in 1 CARTON10/01/2020
    5120 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:55111-118-181 in 1 CARTON09/30/2006
    6180 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:55111-118-244 in 1 CARTON09/30/2006
    76 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:55111-118-353 in 1 CARTON09/30/2006
    86 in 1 BLISTER PACK; Type 0: Not a Combination Product
    9NDC:55111-118-813 in 1 CARTON09/30/2006
    910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    10NDC:55111-118-791 in 1 CARTON09/30/2006
    1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    11NDC:55111-118-121 in 1 CARTON09/30/2006
    1112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07736709/30/2006
    FAMOTIDINE 
    famotidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-396
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code L1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55111-396-351 in 1 CARTON09/30/2006
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55111-396-501 in 1 CARTON09/30/2006
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55111-396-651 in 1 CARTON10/01/2020
    365 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:55111-396-901 in 1 CARTON10/07/2021
    490 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:55111-396-442 in 1 CARTON09/30/2006
    5NDC:55111-396-01100 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:55111-396-131 in 1 CARTON10/01/2020
    6130 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:55111-396-321 in 1 CARTON09/30/2006
    7170 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:55111-396-081 in 1 CARTON09/30/2006
    88 in 1 BLISTER PACK; Type 0: Not a Combination Product
    9NDC:55111-396-165 in 1 CARTON09/30/2006
    95 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07736709/30/2006
    Labeler - Dr.Reddys Laboratories Limited (650562841)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.Reddys Laboratories Limited918608162analysis(55111-118, 55111-396) , manufacture(55111-118, 55111-396)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reed Lane Inc001819879pack(55111-118, 55111-396)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Reddy's Laboratories Louisiana LLC830397282analysis(55111-118, 55111-396) , manufacture(55111-118, 55111-396)
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