FDA.reportPublic FDA data

Rugby Calcium Carbonate 10 gr

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2016-06-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:25:19

Label at a glance#

ProductRugby Calcium Carbonate 10 gr
Active ingredientCALCIUM CARBONATE
Label structure10 sections

Indications and uses

Relieves: acid indigestion heartburn sour stomach acid indigestion 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#

Active ingredient

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
  • acid indigestion
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

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

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

If pregnant or breast-feeding, 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 2 weeks

Other Information

SPL UNCLASSIFIED SECTION

each tablet contains: calcium 260mg

store at room temperature 150-300C (590-860F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, magnesium stearate, maltodextrin

Questions or comments

OTC - QUESTIONS SECTION

1-800-645-2158

Repackaging Information

SPL UNCLASSIFIED SECTION

This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count648mg
3043353-958-30
6043353-958-53
9043353-958-60
10043353-958-65
18043353-958-80
20043353-958-85
27043353-958-92

Store between 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20160606DH

PRINCIPAL DISPLAY PANEL - 648mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43353-958 - Calcium Carbonate 648mg - Rx Only
Bottle Label 648mgBottle Label 648mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-958RUGBY CALCIUM CARBONATE 10 GR (ANTACID TABLETS) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20160711_1a92abe8-8310-4ac2-92fe-27dd72ccce50.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-958-30EA - Each43353-958c806bf96-6c59-4731-ac9b-2e21435aa71712016-07-19
43353-958-53EA - Each43353-95819dd3a3b-9fe2-47d6-998e-1ff04fa1011212016-07-19
43353-958-60EA - Each43353-95853c00a91-b221-4812-ae07-2a49342561ef12016-07-19
43353-958-65EA - Each43353-9584b2477a6-7a1d-44af-9638-cc6dc607e67012016-07-19
43353-958-80EA - Each43353-9584918107e-68f4-442e-bf0e-8acfabecb13e12016-07-19
43353-958-85EA - Each43353-9589d33682f-575c-4519-aeb8-f9af1bc9a99612016-07-19
43353-958-92EA - Each43353-958c4ce2d9d-80b3-4bc8-b62f-73be288755c012016-07-19
0536-1024-10EA - Each0536-102495025046-748c-4a2e-8e8a-cbecb1906ac612014-09-03

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43353-95843353-958-30, 43353-958-53, 43353-958-60, 43353-958-65, 43353-958-80, 43353-958-85, 43353-958-92
0536-1024

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
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT

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
36ee6be5-5eab-31d2-e063-6394a90a82611a92abe8-8310-4ac2-92fe-27dd72ccce502025-06-06WarningsExact identifier
spl set id: 1a92abe8-8310-4ac2-92fe-27dd72ccce50

Reported adverse events (FAERS/openFDA)#

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