FDA Label for Calcium Carbonate
View Indications, Usage & Precautions
Calcium Carbonate Product Label
The following document was submitted to the FDA by the labeler of this product Hikma Pharmaceuticals Usa Inc.. 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.
Calcium Carbonate Oral Suspension (Not Usp)
Calcium Supplement
Supplement Facts
Serving Size: 5 mL (teaspoonful) | |
Amount Per Serving | % Daily Value |
Calcium 500 mg | 50 % |
Active Ingredient
Each 5 mL (teaspoonful) delivers 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium).
Purpose
Antacid
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.
Uses
Use for the prevention of calcium deficiency in adults.
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.
Directions
Shake well before using. Take 5 mL (one teaspoonful) two to three times daily with meals or as directed by a physician.
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
Inactive Ingredients
Methylparaben, propylene glycol, propylparaben, purified water, sodium hypochlorite solution, sorbitol solution, spearmint flavor, xanthan gum.
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
Package/Label Principal Display Panel
CALCIUM CARBONATE Oral Suspension (not USP)
0054-3117-63: 1250mg/5mL (provides 500mg elemental calcium per 5mL)
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