CALCIUM CARBONATE suspension

Calcium Carbonate by

Drug Labeling and Warnings

Calcium Carbonate by is a Otc medication manufactured, distributed, or labeled by West-Ward Pharmaceuticals Corp., West-Ward Columbus Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE 
calcium carbonate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0054-3117
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	1250 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
1-PROPOXY-2-PROPANOL (UNII: 152BY1743W)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
SPEARMINT (UNII: J7I2T6IV1N)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0054-3117-63	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	11/18/2004

Labeler - West-Ward Pharmaceuticals Corp. (080189610)

Establishment
Name	Address	ID/FEI	Business Operations
West-Ward Columbus Inc.		058839929	MANUFACTURE(0054-3117)