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| Product NDC Code | 0121-0766 | ||||
|---|---|---|---|---|---|
| Drug Name | Calcium carbonate |
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| Type | Generic | ||||
| Pharm Class | Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| Application Number | M001 | ||||
| Labeler Name | PAI Holdings, LLC dba PAI Pharma | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL teaspoonful) Calcium Carbonate 1250 mg (Equivalent to 500 mg elemental Calcium)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Shake well before using. Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Relieves: heartburn acid indigestion sour stomach upset stomach associated with these symptoms
Purpose
Information about the drug product’s indications for use.Purpose Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Calcium Carbonate Calcium Carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION D&C RED NO. 33 SACCHARIN CALCIUM WATER PROPYLPARABEN METHYLPARABEN PROPYLENE GLYCOL SORBITOL GLYCERIN XANTHAN GUM ANHYDROUS CITRIC ACID FD&C RED NO. 40 Calcium Carbonate Calcium Carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION PROPYLPARABEN METHYLPARABEN PROPYLENE GLYCOL SORBITOL GLYCERIN XANTHAN GUM ANHYDROUS CITRIC ACID FD&C RED NO. 40 D&C RED NO. 33 SACCHARIN CALCIUM WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0766-16 Quality ® Value Calcium Carbonate Oral Suspension 1250 mg/5 mL Maximum Strength ANTACID Daily source of calcium SUGAR FREE / ALCOHOL FREE SODIUM FREE 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 Principal Display Panel - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label Delivers 5 mL NDC 0121-4766-05 Calcium Carbonate Oral Suspension 1250 mg/5 mL (equivalent to 500 mg of elemental Calcium) ANTACID – SHAKE WELL Package Not Child-Reistant Pharmaceutical Associates, Inc. Greenville, SC 29605 SEE INSERT A0766051021 PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 R07/20
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-800-845-8210. You may also report serious side effects to this phone number.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20° - 25°C (68° - 77°F) do not freeze Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms: NDC 0121-0766-16: 16 fl oz (473 mL) bottle NDC 0121-4766-05: 5 mL unit dose cup, in a tray of ten cups.
| NDC 0121-0766-16: | 16 fl oz (473 mL) bottle |
| NDC 0121-4766-05: | 5 mL unit dose cup, in a tray of ten cups. |
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks. Keep out of reach of children.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API