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MINTOX MAXIMUM STRENGTH

Mintox Max

Approved
Approval ID

ac6a47e7-972f-4b82-96da-89926d345e9f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

aluminum hydroxide, magnesium hydroxide, dimethicone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17856-5725
Application NumberM
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide, magnesium hydroxide, dimethicone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (14)

BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 400 mg in 5 mL
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM HYDROXIDEActive
Quantity: 400 mg in 5 mL
Code: NBZ3QY004S
Classification: ACTIB
DIMETHICONEActive
Quantity: 40 mg in 5 mL
Code: 92RU3N3Y1O
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/30/2024

MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE,

DIMETHICONE) SUSPENSION

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/14/2013

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • the symptoms referred to as gas

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/30/2024

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/14/2013

Purposes

Antacid

Antigas

WARNINGS SECTION

LOINC: 34071-1Updated: 10/16/2019

Warnings

Ask a doctor before use if you have

• kidney disease

• a magnesium-restricted diet

taking a prescription drug.**Ask a doctor or pharmacist before use if you are **


Antacids may interact with certain prescription drugs.

symptoms last more than 2 weeksStop use and ask a doctor if

ask a health professional before use.If pregnant or breast-feeding,

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/14/2013

Directions

• shake well before use

• do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

• adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor

• children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/14/2013

Other information

• magnesium 165 mg, sodium 1 mgeach 5 mL teaspoonful contains:

• store at room temperature

• protect from freezing

• keep tightly closed

TAMPER-EVIDENT: Do not use if breakaway band on bottle cap is missing or broken.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/14/2013

Inactive ingredients

benzyl alcohol, butylparaben, caramel color, carboxymethylcellulose sodium, D and C yellow no.10, flavor, glycerin, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

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MINTOX MAXIMUM STRENGTH - FDA Drug Approval Details