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| Product NDC Code | 0054-3117 | ||||
|---|---|---|---|---|---|
| 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] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| RxCUI drug identifier | 308891 | ||||
| Application Number | part331 | ||||
| Labeler Name | Hikma Pharmaceuticals USA Inc. | ||||
| 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 Each 5 mL (teaspoonful) delivers 1250 mg calcium carbonate (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 5 mL (one teaspoonful) two to three times daily with meals or as directed by a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Methylparaben, propylene glycol, propylparaben, purified water, sodium hypochlorite solution, sorbitol solution, spearmint flavor, 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 Use for the prevention of calcium deficiency in adults.
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 SORBITOL 1-PROPOXY-2-PROPANOL XANTHAN GUM METHYLPARABEN SPEARMINT SODIUM HYPOCHLORITE
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.Package/Label Principal Display Panel CALCIUM CARBONATE Oral Suspension (not USP) 0054- 3117 -63: 1250mg/5mL (provides 500mg elemental calcium per 5mL) label-4114101-09.jpg
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.CALCIUM CARBONATE Oral Suspension (not USP) Calcium Supplement
Supplement Facts Serving Size: 5 mL (teaspoonful) Amount Per Serving % Daily Value Calcium 500 mg 50 %
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 Keep bottle tightly closed. Store in a cool, dry place, out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
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 1-800-962-8364. You may also report serious side effects to this phone number. Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 4043502//04 Revised November 2016
Storage and handling
Information about safe storage and handling of the drug product.Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep from freezing. Sodium content: 0 mg per 5 mL
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 Do not use more than directed. As with any supplement, if you are pregnant or nursing a baby, contact your healthcare professional before use. The seal of the package bears our name, Roxane. If the seal is broken or our name does not appear, do not use.
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