FDA.reportPublic FDA data

Calcium Carbonate Tablets, USP 10gr (648 mg)

Manufacturer
CitraGen Pharmaceuticals, Inc.
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:54:03

Label at a glance#

ProductCalcium Carbonate 10 gr (648 mg)
Active ingredientCALCIUM CARBONATE
Label structure10 sections

Indications and uses

relieves: acid indigestion heartburn sour stomach upset stomach associated with these symptoms

Dosage and administration

take one to four tablets daily do not take more than 4 tablets in 24 hours do not use the maximum dosage for more than 2 weeks

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Calcium carbonate 10 gr (648 mg)

Purpose

OTC - PURPOSE SECTION

Antacid / Calcium Supplement

Uses

INDICATIONS & USAGE SECTION

relieves:

  • acid indigestion
  • heartburn
  • 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 taking a prescription drug.

Antacids may interact with certain prescription drugs.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms last more than 2 weeks.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take one to four tablets daily
  • do not take more than 4 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

Other information

OTHER SAFETY INFORMATION

each tablet contains: Calcium 260 mg

store at room temperature 15º - 30º C (59º - 86º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hydrogenated Vegetable Oil, Maltodextrin and Microcrystalline Cellulose

Questions or comments?

OTC - QUESTIONS SECTION

Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: info@citragenpharma.com

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:
CitraGen Pharmaceuticals, Inc.,
Fremont, CA 94538.

www.citragenpharma.com

Rev. 07/18 R-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369-004-01

Calcium Carbonate Tablets, USP 10 gr (648 mg)

ANTACID / Calcium Supplement

1000 Tablets

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

70369-004-01_Bottle_Label70369-004-01_Bottle_Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
577040calcium carbonate 648 MG (Ca 260 MG) Oral TabletPSN4
577040calcium carbonate 648 MG Oral TabletSCD4
577040calcium carbonate 648 MG (as calcium 260 MG) Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70369-004-01Calcium Carbonate10 gr (648 mg)1000 in 1 BOTTLETABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70369-004CALCIUM CARBONATE 10 GR (648 MG) (CALCIUM CARBONATE) TABLET [CITRAGEN PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20250131_723b940d-4f4b-f2e6-e053-2991aa0a8bcc.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70369-00470369-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
HYDROGENATED COTTONSEED OILZ82Y2C65EAIACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium Carbonate 10 gr (648 mg)CALCIUM CARBONATECitraGen Pharmaceuticals, Inc.723b940d-4f4b-f2e6-e053-2991aa0a8bcc2025-01-30WarningsExact identifier
ndc (package): 70369-004-01
ndc (product): 70369-004
ndc11 (package): 70369000401
spl id: 2ce80b88-058a-5a9b-e063-6294a90af130
spl set id: 723b940d-4f4b-f2e6-e053-2991aa0a8bcc

Reported adverse events (FAERS/openFDA)#

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