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  5. Label Information: Calmicid Ac Acid Reducer

FDA Label for Calmicid Ac Acid Reducer

View Indications, Usage & Precautions

Table of Contents

    1. OTC - PURPOSE
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. OTC - ACTIVE INGREDIENT
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. BOXED WARNING
    15. GENERAL PRECAUTIONS
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calmicid Ac Acid Reducer Product Label

The following document was submitted to the FDA by the labeler of this product Melaleuca, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - 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


Otc - 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

Otc - 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

Otc - 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

Otc - Pregnancy Or Breast Feeding



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


Otc - 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

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


Otc - Questions



Questions or comments?
1-800-282-3000


Boxed Warning



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


General Precautions



Other information

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

Package Label.Principal Display Panel



image of box - calmicidacbox

image of box - calmicidacbox


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