CALCIUM CARBONATE - calcium carbonate suspension 
Roxane Laboratories, Inc

----------

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