Label: ACID REDUCER PLUS ANTACID- famotidine, calcium carbonate, magnesium hydroxide tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 3, 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

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  • Purpose

    Acid reducer

    Antacid

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  • Use

    relieves heartburn associated with acid indigestion and sour stomach

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  • Warnings

    Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

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  • 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
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  • 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
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  • Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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  • Stop use and ask a doctor if

    your heartburn continues or worsens
    you need to take this product for more than 14 days
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • 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).

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  • 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
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  • Other information

    each tablet contains: calcium 335 mg; magnesium 80 mg
    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
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  • Inactive ingredients

    anhydrous lactose, crospovidone, D&C yellow #10 aluminum lake, ethylcellulose aqueous dispersion, FD&C yellow #6 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, isomalt, magnesium stearate, maltodextrin, mannitol, mineral oil, natural and artificial tropical type flavor, polysorbate 80, sodium metabisulfite, sucralose, talc, triethyl citrate

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Compare to the active ingredients in Pepcid Complete®

    Dual-Action Complete

    Acid Reducer Plus Antacid

    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

    Tropical Fruit Flavor

    Actual Size

    50 CHEWABLE TABLETS

    802-17-acid-reducer-plus-antacid.jpg
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  • INGREDIENTS AND APPEARANCE
    ACID REDUCER PLUS ANTACID 
    famotidine, calcium carbonate, magnesium hydroxide tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-802
    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) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 800 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 165 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOMALT (UNII: S870P55O2W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    Product Characteristics
    Color YELLOW (Mottled, yellow-orange and white) Score no score
    Shape ROUND Size 17mm
    Flavor FRUIT Imprint Code Plus
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69842-802-71 50 in 1 BOTTLE; Type 0: Not a Combination Product 04/03/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA204782 04/03/2018
    Labeler - CVS Pharmacy (062312574)
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