GOOD SENSE DUAL ACTION COMPLETE (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [L PERRIGO COMPANY]

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GOOD SENSE DUAL ACTION COMPLETE (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [L PERRIGO COMPANY]
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NDC 0113-0032-63
Set ID b7154648-8c8c-4ce6-88b7-5442a16143c5
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number ANDA077355
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  • Active ingredients (in each chewable tablet)

    Famotidine 10 mg

    Calcium carbonate 800 mg

    Magnesium hydroxide 165 mg

  • Purposes

    Acid reducer

    Antacid

  • Use

    relieves heartburn associated with acid indigestion and sour stomach

  • 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. Antacids and 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

    •
    adults and children 12 years and over:
    •
    do not swallow tablet whole: chew completely
    •
    to relieve symptoms, chew 1 tablet before swallowing
    •
    do not use more than 2 chewable tablets in 24 hours
    •
    children under 12 years: ask a doctor
  • Other information

    •
    each tablet contains: calcium 330 mg; magnesium 80 mg
    •
    Phenylketonurics: Contains Phenylalanine 2 mg per tablet
    •
    read the directions and warnings before use
    •
    read the bottle. It contains important information.
    •
    store at 20-25°C (68-77°F)
    •
    protect from moisture
  • Inactive ingredients

    anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Dual Action Complete

    See New Warnings

    Famotidine 10 mg/Calcium Carbonate 800 mg/Magnesium Hydroxide 165 mg Tablets (Chewable)

    Acid Reducer plus Antacid

    Just One Tablet! Relieves Heartburn Due to Acid Indigestion

    Actual Size

    Berry Flavor

    25 Chewable Tablets

    Compare to active ingredients of Pepcid Complete®

    100% SATISFACTION GUARANTEED

    321-c2-dual-action-complete.jpg
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE DUAL ACTION COMPLETE 
    famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE800 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE165 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    ASPARTAME (UNII: Z0H242BBR1)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    DEXTRATES (UNII: G263MI44RU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINK (mottled) Scoreno score
    ShapeROUND (bi-layered) Size17mm
    FlavorBERRYImprint Code L321
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0032-6325 in 1 BOTTLE; Type 0: Not a Combination Product01/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07735501/06/2016
    Labeler - L. Perrigo Company (006013346)
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