CALCIUM CARBONATE- calcium carbonate suspension 
Hikma Pharmaceuticals USA Inc.

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.

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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)

label-4114101-09.jpg
CALCIUM CARBONATE 
calcium carbonate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0054-3117
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1250 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0054-3117-63500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/18/200405/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/18/200405/31/2024
Labeler - Hikma Pharmaceuticals USA Inc. (080189610)
Establishment
NameAddressID/FEIBusiness Operations
West-Ward Columbus Inc.058839929MANUFACTURE(0054-3117)

Revised: 12/2022
 
Hikma Pharmaceuticals USA Inc.