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family wellness acid controller complete (Family Dollar Services Inc)

Available Formats

Dosage Form Package Information Links
TABLET, CHEWABLE 25 TABLET, CHEWABLE in 1 BOTTLE (55319-321-63) Label Information

Complete family wellness acid controller complete Information

  • Active ingredient (in each chewable tablet)

    Famotidine 10 mg

    Calcium carbonate 800 mg

    Magnesium hydroxide 165 mg


  • Purpose

    Acid reducer

    Antacid


  • Uses

    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 320 mg; magnesium 70 mg
    • Phenylketonurics: Contains phenylalanine 2.2 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?

    1-800-719-9260


  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENTS OF PEPCID COMPLETE®

    Dual Action

    Acid Controller Complete

    Famotidine 10 mg, Calcium Carbonate 800 mg, Magnesium Hydroxide 165 mg Tablets

    Acid Reducer Plus Antacid

    Just One Tablet! Relieves Heartburn Due to Acid Indigestion

    ACTUAL SIZE

    BERRY FLAVOR

    Acid Controller Complete label Image 1
    Acid Controller Complete Label Image 2

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS ACID CONTROLLER COMPLETE 
    famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-321
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 165 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 800 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME (UNII: Z0H242BBR1)  
    DEXTRATES (UNII: G263MI44RU)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color PINK (mottled) Score no score
    Shape ROUND (bi-layered) Size 17mm
    Flavor BERRY Imprint Code L321
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55319-321-63 25 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077355 08/02/2012
    Labeler - Family Dollar Services Inc (024472631)