Home > Drugs A-Z > Calmicid AC

Calmicid AC (Melaleuca, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1 BOTTLE in 1 BOX (54473-203-50) > 50 TABLET, FILM COATED in 1 BOTTLE Label Information

Complete Calmicid AC Information

  • BOXED WARNING(What is this?)

    DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING


  • PURPOSE

    Purpose
    Acid reducer


  • INDICATIONS & USAGE

    Use

    • relieves heartburn associated with acid indigestion and sour stomach
    • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

  • WARNINGS

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


  • DO NOT USE

    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.
    • if you have kidney disease, except under the advice and supervision of a doctor
    • with other acid reducers

  • ASK DOCTOR

    Ask a doctor before use if you have

    • had heartburn over three 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

  • STOP USE

    Stop use and ask a doctor if

    • your heartburn continues or worsens
    • you need to take this product for more than 14 days

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case  of overdose, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years and over:
      • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
      • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
      • do not use more than 2 tablets in 24 hours
    • children under 12 years: ask a doctor

  • ACTIVE INGREDIENT


    Active ingredient (in each tablet)
    Famotidine 20 mg

  • STORAGE AND HANDLING

    Other information

    • store at 20°-25°C (68°-77°F)
    • protect from moisture and light

  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide


  • QUESTIONS

    Questions or comments?
    1-800-282-3000


  • GENERAL PRECAUTIONS

    Other information

    • read the directions and warnings before use
    • keep the carton, it contains important information.

  • INGREDIENTS AND APPEARANCE
    CALMICID AC  ACID REDUCER
    loratadine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-203
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Lactose monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (biconvex) Size 8mm
    Flavor Imprint Code L194
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54473-203-50 1 in 1 BOX
    1 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090283 01/20/2011
    Labeler - Melaleuca, Inc. (139760102)