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Calcium Carbonate oral suspension(碳酸钙口服混悬液)

2014-11-27 13:16:09  作者:新特药房  来源:互联网  浏览次数:75  文字大小:【】【】【
简介: 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 ...

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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