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 November 19, 2019

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

  • 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 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
  • 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

  • Questions or comments?

    1-800-719-9260

  • 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
  • INGREDIENTS AND APPEARANCE
    ACID REDUCER PLUS ANTACID 
    famotidine, calcium carbonate, magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-802
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE800 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE165 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 (1600000 WAMW) (UNII: RFW2ET671P)  
    Product Characteristics
    ColorYELLOW (Mottled, yellow-orange and white) Scoreno score
    ShapeROUNDSize17mm
    FlavorFRUITImprint Code Plus
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-802-7150 in 1 BOTTLE; Type 0: Not a Combination Product04/03/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20478204/03/2018
    Labeler - CVS Pharmacy (062312574)