TC MAX- calcium carbonate powder, for solution 
TC MAX- calcium carbonate 
Romavision Investing LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active Ingredients (In each packet)

Calcium Carbonate (4000mg)

Purpose

Antacid

Indications

For the relief of:

Warnings

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

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

Ask a doctor before use if you have

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

Keep this and all drugs out of the reach of children

Drug Interactions

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

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

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

Inactive Ingredients:

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

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

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
TC MAX 
calcium carbonate powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80733-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
calcium carbonate (UNII: H0G9379FGK) (calcium cation - UNII:2M83C4R6ZB) calcium carbonate4 g  in 237 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
SUNFLOWER OIL MONO/DIGLYCERIDES (UNII: HS7EB0C1ZH)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
XANTHAN GUM (UNII: TTV12P4NEE)  
NEOTAME (UNII: VJ597D52EX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
THAUMATIN (UNII: KNC9Q0EE6G)  
SUCROSE (UNII: C151H8M554)  
ADVANTAME (UNII: 3ZA6810AWX)  
ACACIA SENEGAL WHOLE (UNII: QP4QYZ033C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80733-005-01237 mL in 1 PACKET; Type 0: Not a Combination Product07/18/2019
2NDC:80733-005-055 in 1 BOX07/18/2019
2NDC:80733-005-01237 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/03/2019
TC MAX 
calcium carbonate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80733-007
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80733-007-061 in 1 BOX07/18/2019
11 in 1 KIT; Type 1: Convenience Kit of Co-Package
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 PACKET 1422 mL
Part 1 of 1
TC MAX 
calcium carbonate powder, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
calcium carbonate (UNII: H0G9379FGK) (calcium cation - UNII:2M83C4R6ZB) calcium carbonate4 g  in 237 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
SUNFLOWER OIL MONO/DIGLYCERIDES (UNII: HS7EB0C1ZH)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
XANTHAN GUM (UNII: TTV12P4NEE)  
NEOTAME (UNII: VJ597D52EX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
THAUMATIN (UNII: KNC9Q0EE6G)  
SUCROSE (UNII: C151H8M554)  
ADVANTAME (UNII: 3ZA6810AWX)  
ACACIA SENEGAL WHOLE (UNII: QP4QYZ033C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 NOT APPLICABLE
1237 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33107/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33107/18/2019
Labeler - Romavision Investing LLC (080808687)
Establishment
NameAddressID/FEIBusiness Operations
Identipak, Inc.942862350MANUFACTURE(80733-005, 80733-007)

Revised: 12/2022
Document Id: 2cf2f216-3e2a-461f-8cfd-d1a1a859ce00
Set id: b1024e59-59c7-2df8-e053-2a95a90a48ef
Version: 7
Effective Time: 20221229
 
Romavision Investing LLC