Label: DUAL ACTION COMPLETE- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

  • NDC Code(s): 30142-040-63, 30142-040-71
  • Packager: Kroger Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 10, 2018

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

  • 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

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug. Antacids 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 label. 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?

    1-800-632-6900

  • Principal Display Panel

    COMPARE TO the active ingredients of PEPCID COMPLETE® See back panel

    DUAL ACTION COMPLETE

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

    ACID REDUCER + ANTACID

    Just One Tablet! Relieves Heartburn Due to Acid Indigestion

    Our Pharmacists Recommend

    Berry Flavor

    actual size

    50 CHEWABLE TABLETS

    dual-action-complete-image
  • INGREDIENTS AND APPEARANCE
    DUAL ACTION COMPLETE 
    famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE165 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE800 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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (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:30142-040-6325 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
    2NDC:30142-040-7150 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07735502/01/2016
    Labeler - Kroger Company (006999528)