CALCIUM CARBONATE-calcium carbonate suspension(中文药名:碳酸钙口服混悬液) Roxane Laboratories, Inc 本品为制酸剂、补钙剂:应用于胃酸过多(多为复方可供选用的上市品种)和低血钙症引发的骨软化、佝偻病、肾性骨营养不良、骨质疏松、肌肉疼痛、抽搐、痉挛,以及老年人和妊娠、绝经期妇女的饮食补充。 CALCIUM CARBONATE Oral Suspension (not USP) CALCIUM SUPPLEMENT Active ingredient Each 5 mL delivers 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium).
Uses For use in the prevention of calcium deficiency in adults when needed, or directed by a physician. This product supplied as 5 mL Patient Cups™ is for use only at the direction of a physician and under professional supervision. Except in unit dose quantities the usual dose is 5 mL two to three times daily with meals, or as directed by a physician. Do not use more than directed. As with any supplement, if you are pregnant or nursing a baby, contact your healthcare professional before use. Warnings Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. Directions Shake well before using. Inactive ingredients Methylparaben, propylene glycol, propylparaben, purified water, sodium hypochlorite solution, sorbitol solution, spearmint flavor, and xanthan gum. Sodium content: 0 mg per 5 mL How Supplied 0054-8116-16: Unit dose Patient Cups™ filled to deliver 5 mL, ten 5 mL Patient Cups™ per shelf pack, four shelf packs per shipper. 0054-3117-63: Bottles of 500 mL. Storage Store at Controlled Room Temperature 15° to 30°C (59° to 86°F). KEEP FROM FREEZING Questions or comments? Call 1-800-962-8364 4043502//02 Revised April 2008 © RLI, 2008 Package Label - CALCIUM CARBONATE Oral Suspension 0054-8116-16: Unit dose Patient Cups™ filled to deliver 5 mL, ten 5 mL Patient Cups™ per shelf pack, four shelf packs per shipper. 0054-3117-63: Bottles of 500 mL.
CALCIUM CARBONATE calcium carbonate suspension Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0054-8116 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 1250 mg in 5 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM HYPOCHLORITE SORBITOL XANTHAN GUM Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 0054-8116-16 5 mL In 1 CUP, UNIT-DOSE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part357A 11/24/2009 Labeler - Roxane Laboratories, Inc (058839929) Registrant - Roxane Laboratories, Inc (058839929) Establishment Name Address ID/FEI Operations Boehringer Ingelheim Roxane Inc 128407710 MANUFACTURE Revised: 11/2009Roxane Laboratories, Inc
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