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

TC Max by

Drug Labeling and Warnings

TC Max by is a Otc medication manufactured, distributed, or labeled by Romavision Investing LLC, Identipak, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Vanilla Ice Cream
Flavor

TC MAX

Starter Kit

Buffered Suspension

Corn Free       Soy Free        Protein Free        Dairy Free        Non GMO

INGREDIENTS AND APPEARANCE

TC MAX 
calcium carbonate powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80733-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
calcium carbonate (UNII: H0G9379FGK) (calcium cation - UNII:2M83C4R6ZB)	calcium carbonate	4 g  in 237 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80733-005-01	237 mL in 1 PACKET; Type 0: Not a Combination Product	07/18/2019
2	NDC: 80733-005-05	5 in 1 BOX	07/18/2019
2	NDC: 80733-005-01	237 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	06/03/2019

TC MAX 
calcium carbonate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80733-007

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80733-007-06	1 in 1 BOX	07/18/2019
1		1 in 1 KIT; Type 1: Convenience Kit of Co-Package

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 PACKET	1422 mL

Part 1 of 1

TC MAX 
calcium carbonate powder, for solution

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
calcium carbonate (UNII: H0G9379FGK) (calcium cation - UNII:2M83C4R6ZB)	calcium carbonate	4 g  in 237 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		6 in 1 NOT APPLICABLE
1		237 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	07/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	07/18/2019

Labeler - Romavision Investing LLC (080808687)

Establishment
Name	Address	ID/FEI	Business Operations
Identipak, Inc.		942862350	MANUFACTURE(80733-005, 80733-007)