Calcium Carbonate

Manufacturer: Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.
Effective date: 2022-12-19
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 21:43:47

Label at a glance#

ProductCalcium Carbonate

Active ingredientCALCIUM CARBONATE

Label structure12 sections

Indications and uses

Use for the prevention of calcium deficiency in adults.

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-800-962-8364

Label contents#

Full prescribing information#

CALCIUM CARBONATE Oral Suspension (not USP)

SPL UNCLASSIFIED SECTION

Calcium Supplement

Supplement Facts

SPL UNCLASSIFIED SECTION

Serving Size: 5 mL (teaspoonful)
Amount Per Serving	% Daily Value
Calcium 500 mg	50 %

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Each 5 mL (teaspoonful) delivers 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium).

Purpose

OTC - PURPOSE SECTION

Antacid

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Use for the prevention of calcium deficiency in adults.

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

Methylparaben, propylene glycol, propylparaben, purified water, sodium hypochlorite solution, sorbitol solution, spearmint flavor, xanthan gum.

Questions or Comments

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALCIUM CARBONATE Oral Suspension (not USP)

0054-3117-63: 1250mg/5mL (provides 500mg elemental calcium per 5mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-3117-63	ML - Milliliter	0054-3117	f14bde6f-7bfd-4ee5-aa1c-01f1710253f7	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	3
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	3
1-PROPOXY-2-PROPANOL	INACTIVE INGREDIENT	152BY1743W	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
SODIUM HYPOCHLORITE	INACTIVE INGREDIENT	DY38VHM5OD	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
SPEARMINT	INACTIVE INGREDIENT	J7I2T6IV1N	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Calcium Carbonate
CALCIUM CATION
SORBITOL
1-PROPOXY-2-PROPANOL
XANTHAN GUM
METHYLPARABEN
SPEARMINT
SODIUM HYPOCHLORITE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0054-3117	0054-3117-63

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALCIUM CARBONATE	H0G9379FGK	ACTIB
SORBITOL	506T60A25R	IACT
1-PROPOXY-2-PROPANOL	152BY1743W	IACT
XANTHAN GUM	TTV12P4NEE	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
SPEARMINT	J7I2T6IV1N	IACT
SODIUM HYPOCHLORITE	DY38VHM5OD	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 157 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SPEARMINT	SPEARMINT	J7I2T6IV1N	TABLET, ORALLY DISINTEGRATING / ORAL	0.06 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SPEARMINT	SPEARMINT	J7I2T6IV1N	SOLUTION / ORAL	0.04 ml/5ml		Exact identifier — unii candidate 4 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	CREAM / TOPICAL		46 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8c0aefee-0ab5-4a1b-9a5f-0107ab3e0681			594e80a9-b2fa-4a69-ab70-c25e78b1a40d	2022-12-19	Warnings	Exact identifier spl id: 8c0aefee-0ab5-4a1b-9a5f-0107ab3e0681 spl set id: 594e80a9-b2fa-4a69-ab70-c25e78b1a40d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.