FDA.reportPublic FDA data

Calcium Carbonate 10 gr (648 mg)

Manufacturer
RUGBY LABORATORIES | Pharbest Pharmaceuticals Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:44:22

Label at a glance#

ProductCalcium Carbonate 10 gr (648 mg) (Antacid)
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 two weeks

Storage and handling

each tablet contains: calcium 260 mg store at room temperature

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 10 gr (648 mg)

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION


Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney stones
  • a calcium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms last more than 2 weeks.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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 two weeks

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 260 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

SPL UNCLASSIFIED SECTION

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

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0536-1206-10

Rugby ®

Calcium

Carbonate

10 gr (648 mg)

ANTACID

1000 TABLETS

Rugby Calcium Carbonate 10 gr Product LabelRugby Calcium Carbonate 10 gr Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
577040calcium carbonate 648 MG (Ca 260 MG) Oral TabletPSN3
577040calcium carbonate 648 MG Oral TabletSCD3
577040calcium carbonate 648 MG (as calcium 260 MG) Oral TabletSY3

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
0536-1206-10Calcium Carbonate 10 gr (648 mg)(Antacid)1000 in 1 BOTTLE, PLASTICTABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1206CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) (CALCIUM CARBONATE 10GR (648 MG)) TABLET [RUGBY LABORATORIES]3Current NDC, Legacy NDC, 1 package rows20241219_f21c8cf7-45cb-492b-bf4a-462024a54569.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1206-10EA - Each0536-12069bf7c545-3812-4fa5-a1d9-3820e437cb6312019-07-02

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12060536-1206-10

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
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ACACIA5C5403N26OIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML · Source PDF

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) (Antacid)CALCIUM CARBONATE 10GR (648 MG)RUGBY LABORATORIESf21c8cf7-45cb-492b-bf4a-462024a545692024-12-17WarningsExact identifier
ndc (package): 0536-1206-10
ndc (product): 0536-1206
ndc11 (package): 00536120610
spl id: 93da1b3c-e50a-407d-96cf-6f2b215539da
spl set id: f21c8cf7-45cb-492b-bf4a-462024a54569

Reported adverse events (FAERS/openFDA)#

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