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care one acid reducer and antacid (American Sales Company)

Available Formats

Dosage Form Package Information Links
TABLET, CHEWABLE 30 TABLET, CHEWABLE in 1 BOTTLE (41520-546-65) Label Information
TABLET, CHEWABLE 25 TABLET, CHEWABLE in 1 BOTTLE (41520-546-63) Label Information

Complete care one acid reducer and antacid Information

  • Active ingredients (in each chewable tablet)

    Famotidine 10 mg

    Calcium carbonate 800 mg

    Magnesium hydroxide 165 mg


  • Purpose

    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 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, aspartame, dextrates, ferric oxide, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, natural peppermint flavor, 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 in Pepcid Complete®

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

    ACID REDUCER + ANTACID

    DUAL ACTION

    Just One Tablet Relieves Heartburn Due to Acid Indigestion

    Actual Size

    Cool Mint Flavor

    25 CHEWABLE TABLETS

    CareOne Acid Reducer + Antacid image

  • INGREDIENTS AND APPEARANCE
    CARE ONE ACID REDUCER AND ANTACID  DUAL ACTION
    famotidine, calcium carbonate, magnesium hydroxide tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-546
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 800 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 165 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    ASPARTAME (UNII: Z0H242BBR1)  
    DEXTRATES (UNII: G263MI44RU)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONES (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color ORANGE (PEACH WITH WHITE SPECKLES) Score no score
    Shape ROUND Size 18mm
    Flavor MINT Imprint Code L546
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-546-63 25 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:41520-546-65 30 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077355 08/01/2008
    Labeler - American Sales Company (809183973)