FDA.reportPublic FDA data

Calcium Carbonate 10 gr (648 mg)

Manufacturer
Ulai Health LLC
Effective date
2025-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:19

Label at a glance#

ProductCalcium Carbonate 10 gr (648 mg) (Antacid)
Active ingredientCALCIUM CARBONATE
Label structure9 sections

Indications and uses

for the relief of acid indigestion heartburn sour stomach upset stomach associated with these symptoms

Dosage and administration

 adults and children 12 years and over     take 1 to 4 tablets daily or as directed by a doctor

Storage and handling

each tablet contains: calcium 260 mg store at 20-25 o C (68-77 o F)

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

for the relief of

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

Do not use

OTC - DO NOT USE SECTION

  • more than 4 tablets in 24 hours
  • the maximum dosage for more than two weeks, unless directed by a doctor

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

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

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

 adults and children 12 years and over    take 1 to 4 tablets daily or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 260 mg
  • store at 20-25 oC (68-77 oF)

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 73057-377-11

Manufactured in the USA

Calcium

Carbonate

Antacid

10 gr (648 mg)

1000 TABLETS

Ulai Calcium Carbonate 648 mg Tab 1000 ct. LabelUlai Calcium Carbonate 648 mg Tab 1000 ct. 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73057-377-082022-01-31C16284748780-1d6a99b39-b934-a426-e053-dadaa90af4c2Drug Facts
73057-377-112022-01-31C16284748780-1d6a99b39-b934-a426-e053-dadaa90af4c2Drug Facts
73057-377-082022-01-28C16284748780-1d6a99b39-b934-a426-e053-dadaa90af4c2Drug Facts
73057-377-112022-01-28C16284748780-1d6a99b39-b934-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-377-08Calcium Carbonate 10 gr (648 mg)(Antacid)100 in 1 BOTTLE, PLASTICTABLET1003
73057-377-11Calcium 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
73057-377CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) (CALCIUM CARBONATE 10GR (648 MG)) TABLET [ULAI HEALTH LLC]3Current NDC, Legacy NDC, 2 package rows20250122_641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a.zip

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
73057-37773057-377-11, 73057-377-08

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

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) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Ulai Health LLC641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a2025-01-20WarningsExact identifier
ndc (package): 73057-377-08
ndc (package): 73057-377-11
ndc (product): 73057-377
ndc11 (package): 73057037708
ndc11 (package): 73057037711
spl id: 2c2a5a1c-0aa7-6253-e063-6294a90a6b5a
spl set id: 641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a

Reported adverse events (FAERS/openFDA)#

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