Label: UP AND UP FAMOTIDINE- famotidine tablet 

  • Label RSS
  • NDC Code(s): 11673-061-02, 11673-061-71, 11673-061-72
  • Packager: Target Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/13

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

  • Active ingredient (in each tablet)

    Famotidine 20 mg

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  • Purpose

    Acid reducer

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  • 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
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  • 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.

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  • 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
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  • 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
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  • Inactive ingredients

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

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  • Questions?

    Call 1-800-910-6874

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  • Principal Display Panel

    maximum strength

    famotidine tablets, 20 mg acid reducer

    Compare to active ingredient in Maximum Strength Pepcid® AC

    just one tablet prevents and relieves heartburn due to acid indigestion

    ACTUAL SIZE

    50 TABLETS

    50 TABLETS

    famotidine tablets image 1
    famotidine tablets image 2
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  • INGREDIENTS AND APPEARANCE
    UP AND UP FAMOTIDINE 
    famotidine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11673-061
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 8mm
    Flavor Imprint Code L194
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-061-71 1 in 1 CARTON
    1 50 in 1 BOTTLE
    2 NDC:11673-061-02 5 in 1 CARTON
    2 5 in 1 BLISTER PACK
    3 NDC:11673-061-72 1 in 1 CARTON
    3 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077351 05/03/2012
    Labeler - Target Corporation (006961700)
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