MedPath

MINTOX MAXIMUM STRENGTH

Approved
Approval ID

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

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 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

NDC Product Code17856-5725
Application NumberM
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 23, 2025
Generic Namealuminum hydroxide, magnesium hydroxide, dimethicone

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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