Label: TC MAX- calcium carbonate powder, for solution
TC MAX- calcium carbonate kit

  • NDC Code(s): 80733-005-01, 80733-005-05, 80733-007-06
  • Packager: Romavision Investing LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 29, 2022

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  • Active Ingredients (In each packet)

    Calcium Carbonate (4000mg)

  • Purpose

    Antacid

  • Indications

    For the relief of:

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

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

    • 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
  • INGREDIENTS AND APPEARANCE
    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)
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