FDA.reportPublic FDA data

TC Max

Manufacturer
Romavision Investing LLC | Identipak, Inc.
Effective date
2022-12-29
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:53:26

Label at a glance#

ProductTC Max
Active ingredientcalcium carbonate
Label structure10 sections

Dosage and administration

Add the entire contents of one packet to 8 ounces of cold water and mix well. Take 4 ounces once per day or as directed by a physician.

Label contents#

Full prescribing information#

Active Ingredients (In each packet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate (4000mg)

Purpose

OTC - PURPOSE SECTION

Antacid

Indications

INDICATIONS & USAGE SECTION

For the relief of:

  • Heartburn
  • Acid Indigestion
  • Sour Stomach
  • Upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

  • Do not take more than 4 ounces in a 24 hour period

OTC - DO NOT USE SECTION

  • Do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If pregnant or breast feeding check with your physician before using

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • kidney disease
  • a magnesium restricted diet
  • a calcium restricted diet

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children

Drug Interactions

DRUG INTERACTIONS SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use

  • If you are presently taking a prescription drug. Antacids may interact with certain prescriptions drugs.

Directions for use

DOSAGE & ADMINISTRATION SECTION

Add the entire contents of one packet to 8 ounces of cold water and mix well. Take 4 ounces once per day or as directed by a physician.

Other information

OTHER SAFETY INFORMATION

Each box contains Calcium 15%, Magnesium .85%, Sodium 2.4%

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Acacia Senegal Whole, Acesulfame-Postasium, Advantame, Artificial Flavor, Glycerin, Magnesium Hydroxide, Neotame, Sodium Bicarbonate, Sucrose, Sunflower Oil Mono and Diglycerides, Tapioca Starch, Thaumatin, Tocopherol Acetate, Tricalcium phosphate, Xanthan Gum

Principal Display Panel - 68 gram Packet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vanilla Ice Cream Flavor

TC MAX

Buffered Suspension

68 grams

Corn Free Soy Free Protein Free Dairy Free Non GMO

Principal Display Panel - 68 gram Packet Label
Principal Display Panel - 68 gram Packet Label

Principal Display Panel - 68 gram Packet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vanilla Ice Cream
Flavor

TC MAX

Starter Kit

Buffered Suspension

Corn Free       Soy Free        Protein Free        Dairy Free        Non GMO

Principal Display Panel - 68 gram Packet Label
Principal Display Panel - 68 gram Packet Label

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80733-005-012025-01-30C16284748780-12cef2736-9960-d83d-e063-dadaa90ab31fDRUG FACTS
80733-005-052025-01-30C16284748780-12cef2736-9960-d83d-e063-dadaa90ab31fDRUG FACTS
80733-007-062025-01-30C16284748780-12cef2736-9960-d83d-e063-dadaa90ab31fDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80733-005-01TC Max237 mL in 1 PACKETPOWDER, FOR SOLUTION2377
80733-005-05TC Max5 in 1 BOXPOWDER, FOR SOLUTION57
80733-007-06TC Max1 in 1 BOXKIT17
80733-007-06TC Max1 in 1 KITKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80733-005TC MAX (CALCIUM CARBONATE) POWDER, FOR SOLUTION TC MAX (CALCIUM CARBONATE) KIT [ROMAVISION INVESTING LLC]7Legacy NDC, 2 package rows20230124_b1024e59-59c7-2df8-e053-2a95a90a48ef.zip
80733-007TC MAX (CALCIUM CARBONATE) POWDER, FOR SOLUTION TC MAX (CALCIUM CARBONATE) KIT [ROMAVISION INVESTING LLC]72 package rows20230124_b1024e59-59c7-2df8-e053-2a95a90a48ef.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80733-00580733-005-01, 80733-005-05
80733-00780733-007-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
calcium carbonateH0G9379FGKACTIB
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
STARCH, TAPIOCA24SC3U704IIACT
MALTODEXTRIN7CVR7L4A2DIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
SUNFLOWER OIL MONO/DIGLYCERIDESHS7EB0C1ZHIACT
SUNFLOWER OIL3W1JG795YIIACT
XANTHAN GUMTTV12P4NEEIACT
NEOTAMEVJ597D52EXIACT
SODIUM BICARBONATE8MDF5V39QOIACT
MAGNESIUM HYDROXIDENBZ3QY004SIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
THAUMATINKNC9Q0EE6GIACT
SUCROSEC151H8M554IACT
ADVANTAME3ZA6810AWXIACT
ACACIA SENEGAL WHOLEQP4QYZ033CIACT
calcium carbonateH0G9379FGKACTIB
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
STARCH, TAPIOCA24SC3U704IIACT
MALTODEXTRIN7CVR7L4A2DIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
SUNFLOWER OIL MONO/DIGLYCERIDESHS7EB0C1ZHIACT
SUNFLOWER OIL3W1JG795YIIACT
XANTHAN GUMTTV12P4NEEIACT
NEOTAMEVJ597D52EXIACT
SODIUM BICARBONATE8MDF5V39QOIACT
MAGNESIUM HYDROXIDENBZ3QY004SIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
THAUMATINKNC9Q0EE6GIACT
SUCROSEC151H8M554IACT
ADVANTAME3ZA6810AWXIACT
ACACIA SENEGAL WHOLEQP4QYZ033CIACT

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
2cf2f216-3e2a-461f-8cfd-d1a1a859ce00b1024e59-59c7-2df8-e053-2a95a90a48ef2022-12-29WarningsExact identifier
spl id: 2cf2f216-3e2a-461f-8cfd-d1a1a859ce00
spl set id: b1024e59-59c7-2df8-e053-2a95a90a48ef

Reported adverse events (FAERS/openFDA)#

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