FDA.reportPublic FDA data

Antacid Calcium Carbonate Tablet, chewable

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:45:17

Label at a glance#

ProductAntacid
Active ingredientCALCIUM CARBONATE
Label structure12 sections

Indications and uses

Relieves Heartburn sour stomach acid indigestion upset stomach due to these symptoms

Dosage and administration

Chew 2 tablets every 2-3 hours or as symptoms occur, repeat hourly if needed.

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 420mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

Relieves

  • Heartburn
  • sour stomach
  • acid indigestion
  • upset stomach due to these symptoms

Directions

DOSAGE & ADMINISTRATION SECTION

Chew 2 tablets every 2-3 hours or as symptoms occur, repeat hourly if needed.

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

  • have kidney disease
  • are taking a prescription drug
  • Antacids may interact with certain prescription drugs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Other Information

SPL UNCLASSIFIED SECTION

  • Store at 15ºC - 30ºC (59ºF - 86ºF)
  • Calcium content per tablet: 168mg
  • Phenylketonurics: each tablet contains 1.5mg phenylalanine

Do not use if packet is open or torn

Tamper Evident

Chewable

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Magnesium Stearate, Aspartame. Croscarmellose Sodium, Maltodextrin, mint flavor, sorbitol

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-296-9067

When using this product

OTC - WHEN USING SECTION

Do not take more than 19 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks except under the advice and supervision of a doctor. If symptoms persist for more than two weeks, stop using this product and see a doctor.

Distributed By:

SPL UNCLASSIFIED SECTION

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

*This product is not manufactured or distributed by GSK, owner of the registered trademark Tums®

Reorder No. 2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CS 2016 Globe Antacid 50pk 031124 CDERCS 2016 Globe Antacid 50pk 031124 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN2
313884calcium carbonate 420 MG Chewable TabletSCD2
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY2

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-142-01Antacid2 in 1 PACKETTABLET22
69396-142-01Antacid50 in 1 BOXTABLET502
69396-142-05Antacid2 in 1 PACKETTABLET22
69396-142-05Antacid10000 in 1 BAGTABLET100002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-142ANTACID (CALCIUM CARBONATE) TABLET [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, 4 package rows20241222_14a7916e-5363-7f1b-e063-6294a90a20aa.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-14269396-142-01, 69396-142-05

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
ASPARTAMEZ0H242BBR1IACT
MAGNESIUM STEARATE70097M6I30IACT
SORBITOL506T60A25RIACT
CALCIUM CARBONATEH0G9379FGKACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MALTODEXTRIN7CVR7L4A2DIACT
MINTFV98Z8GITPIACT

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
AntacidCALCIUM CARBONATETrifecta Pharmaceuticals USA LLC14a7916e-5363-7f1b-e063-6294a90a20aa2024-12-20WarningsExact identifier
ndc (package): 69396-142-01
ndc (package): 69396-142-05
ndc (product): 69396-142
ndc11 (package): 69396014205
ndc11 (package): 69396014201
spl id: 29b42633-bfee-2f64-e063-6294a90ac9cc
spl set id: 14a7916e-5363-7f1b-e063-6294a90a20aa

Reported adverse events (FAERS/openFDA)#

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