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Calcium Carbonate by West-Ward Pharmaceuticals Corp.

Dosage form: suspension
Ingredients: CALCIUM CARBONATE 1250mg in 5mL
Labeler: West-Ward Pharmaceuticals Corp.
NDC Code: 0054-3117

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Supplement Facts

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)

CALCIUM CARBONATE 
calcium carbonate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0054-3117
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE1250 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
1-PROPOXY-2-PROPANOL 
XANTHAN GUM 
METHYLPARABEN 
SPEARMINT 
SODIUM HYPOCHLORITE 
Packaging
#Item CodePackage Description
1NDC:0054-3117-63500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/18/2004
Labeler - West-Ward Pharmaceuticals Corp. (080189610)
Establishment
NameAddressID/FEIOperations
West-Ward Columbus Inc.058839929MANUFACTURE(0054-3117)

Revised: 11/2016
 
West-Ward Pharmaceuticals Corp.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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