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  5. Label Information: Rugby Calcium Carbonate 10 Gr

FDA Label for Rugby Calcium Carbonate 10 Gr

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. QUESTIONS OR COMMENTS
    9. REPACKAGING INFORMATION
    10. PRINCIPAL DISPLAY PANEL - 648MG

Rugby Calcium Carbonate 10 Gr 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



Calcium carbonate 10 gr (648 mg)


Purpose



Antacid


Uses



Relieves:

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

Warnings



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 is 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 2 weeks

Other Information



each tablet contains: calcium 260mg

store at room temperature 150-300C (590-860F)


Inactive Ingredients



corn starch, crospovidone, magnesium stearate, maltodextrin


Questions Or Comments



1-800-645-2158


Repackaging Information



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:

Count648mg
3043353-958-30
6043353-958-53
9043353-958-60
10043353-958-65
18043353-958-80
20043353-958-85
27043353-958-92

Store between 15°-30°C (59°-86°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:

Aphena Pharma Solutions - TN - Aphena

Aphena Pharma Solutions - TN - Aphena


Cookeville, TN 38506

20160606DH


Principal Display Panel - 648Mg



NDC 43353-958 - Calcium Carbonate 648mg - Rx Only

Bottle Label 648mg - 43353 0958 30

Bottle Label 648mg - 43353 0958 30


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