Active Ingredient (In Each Tablet)
Calcium Carbonate 10 gr (648 mg)
Calcium Carbonate 10 Gr (648 Mg) Tablet
FDA Label NDC 71610-301
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Calcium Carbonate 10 Gr (648 Mg) (NDC 71610-301). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding,, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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:
| Count | 648 mg |
| 180 | 71610-301-80 |
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:
Aphena Pharma Solutions (TN)
Cookeville, TN 38506
20190711JH
Principal Display Panel - 648 Mg
NDC 71610-301 - Calcium Carbonate 648 mg Tablets
Bottle Label 648 mg (71610 0301 80)
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