Label: ACID CONTROLLER- famotidine tablet, film coated

  • NDC Code(s): 0363-0701-01, 0363-0701-02, 0363-0701-39, 0363-0701-71, view more
    0363-0701-72, 0363-0701-82
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 8, 2019

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

  • Active ingredient (in each tablet)

    Famotidine 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 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°-25°C (68°-77°F)
    protect from moisture and light
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Maximum Strength Pepcid® AC active ingredient

    Acid Controller

    FAMOTIDINE TABLETS, 20 mg / ACID REDUCER

    MAXIMUM STRENGTH

    Just one tablet prevents & relieves heartburn due to acid indigestion

    25 TABLETS

    ACTUAL SIZE

    194-94-acid-controller-1.jpg
    194-94-acid-controller-2.jpg
  • INGREDIENTS AND APPEARANCE
    ACID CONTROLLER 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0701
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code L194
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0701-711 in 1 CARTON09/26/2006
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-0701-721 in 1 CARTON06/02/2011
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-0701-011 in 1 CARTON10/29/2007
    385 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-0701-0225 in 1 CARTON09/26/2006
    41 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0363-0701-3930 in 1 CARTON04/10/201504/10/2015
    51 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:0363-0701-821 in 1 CARTON05/08/2019
    6200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07735109/26/2006
    Labeler - Walgreen Company (008965063)