Label at a glance#

ProductAntacid

Active ingredientCALCIUM CARBONATE

Label structure11 sections

Dosage and administration

adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Contacts and useful links#

PhoneLabel contact1-800-456-7077

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 750 mg

Purpose

OTC - PURPOSE SECTION

Antacid

INDICATIONS & USAGE SECTION

Uses relieves

heartburn
acid indigestion
sour stomach
upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

do not take more than 10 tablets in 24 hours
if pregnant do not take more than 6 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor
do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

OTHER SAFETY INFORMATION

each tablet contains: calcium 300 mg
store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

dextrose, flavor (peppermint), magnesium stearate, maltodextrin

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-800-456-7077

Principal Display Panel - 750 mg Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec
of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.
Buffalo NY 14215

EXTRA STRENGTH

Antacid

Calcium Carbonate 750 mg

2 Chewable Tablets

Principal Display Panel - 750 mg Pouch Label

Principal Display Panel – 50 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec^®
of America, Inc.

*Compare to the active
ingredient in TUMS^® EX

NDC 61010-4408-1

Antacid

Calcium Carbonate 750 mg – Extra Strength

Fast heartburn relief
Relieves acid indigestion

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Tablets per pouch

Principal Display Panel – 50 Count Carton

Principal Display Panel – 100 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec^®
of America, Inc.

*Compare to the active
ingredient in TUMS^® EX

NDC 61010-4408-2

Antacid

Calcium Carbonate 750 mg – Extra Strength

Fast heartburn relief
Relieves acid indigestion

PUSH TO OPEN

Dispense
through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Tablets per pouch

Principal Display Panel – 100 Count Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308915	calcium carbonate 750 MG (Ca 300 MG) Chewable Tablet	PSN	2
308915	calcium carbonate 750 MG Chewable Tablet	SCD	2
308915	calcium carbonate 750 MG (calcium 300 MG) Chewable Tablet	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CALCIUM CATION Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-4408-0	2023-01-30	C162847	48780-1	f386c649-edba-0266-e053-dadaa90a7c1a	Drug Facts
61010-4408-1	2023-01-30	C162847	48780-1	f386c649-edba-0266-e053-dadaa90a7c1a	Drug Facts
61010-4408-2	2023-01-30	C162847	48780-1	f386c649-edba-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61010-4408-0	Antacid	2 in 1 POUCH	TABLET	2	2
61010-4408-1	Antacid	50 in 1 BOX	TABLET	50	2
61010-4408-2	Antacid	100 in 1 BOX	TABLET	100	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-4408	ANTACID (CALCIUM CARBONATE) TABLET [SAFETEC OF AMERICA, INC.]	2	Legacy NDC, 3 package rows	20200130_fdc3a8b9-3edf-4339-9656-623973b32ea5.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Antacid
calcium carbonate
CALCIUM CATION
DEXTROSE
MAGNESIUM STEARATE
MALTODEXTRIN
PEPPERMINT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61010-4408	61010-4408-0, 61010-4408-1, 61010-4408-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALCIUM CARBONATE	H0G9379FGK	ACTIB
DEXTROSE	IY9XDZ35W2	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
PEPPERMINT	V95R5KMY2B	IACT

Source Document#

Source XML

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
6b955c6f-61cd-47d1-b103-e76d21a7af52			fdc3a8b9-3edf-4339-9656-623973b32ea5	2019-12-30	Warnings	Exact identifier spl id: 6b955c6f-61cd-47d1-b103-e76d21a7af52 spl set id: fdc3a8b9-3edf-4339-9656-623973b32ea5

Reported adverse events (FAERS/openFDA)#

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