FDA Label for Calcium Carbonate 10 Gr (648 Mg) (antacid)

View Indications, Usage & Precautions

Calcium Carbonate 10 Gr (648 Mg) (antacid) Product Label

The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. 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.

Active Ingredient (In Each Tablet)



Calcium Carbonate 10 gr (648 mg)


Purpose



Antacid


Uses



relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms

Ask A Doctor Before Use If You Have



  • kidney stones
  • a calcium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are



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


Stop Use And Ask A Doctor If



symptoms last more than 2 weeks.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Directions



  • take one to four tablets daily
  • do not take more than 4 tablets in 24 hours
  • do not use the maximum dosage for more than two weeks

Other Information



  • each tablet contains: calcium 260 mg
  • store at room temperature

Inactive Ingredients



acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid


Questions Or Comments?



1-800-645-2158


Other



TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.


Repackaging Information



Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count648 mg
18071610-301-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:


Cookeville, TN 38506

20190711JH


Principal Display Panel - 648 Mg



NDC 71610-301 - Calcium Carbonate 648 mg Tablets


* Please review the disclaimer below.