FDA.reportPublic FDA data

MINTOX MAXIMUM STRENGTH

Manufacturer
preferred Pharmaceuticals Inc.
Effective date
2023-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:22:41

Label at a glance#

ProductMINTOX MAXIMUM STRENGTH
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure8 sections

Indications and uses

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

Dosage and administration

• shake well before using • adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day or as directed by a physician • do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks. • children under 12 years: consult a physician

Storage and handling

• each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg • keep tightly closed • store at room temperature and avoid freezing

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

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

Magnesium hydroxide 400 mg

Simethicone 40mg

Purposes

OTC - PURPOSE SECTION

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet

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

Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if symptoms last more than 2 weeks

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day or as directed by a physician
  • do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks.
  • children under 12 years: consult a physician

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg
  • keep tightly closed
  • store at room temperature and avoid freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-8228-3

MAJOR

Relabeled By Preferred Pharmaceuticals Inc.

Mintox

Maximum Strength

antacid/antigas

Alumina, Magnesia and Simethicone Oral Suspension USP

Fast Relief of:

HEARTBURN

ACID INDIGESTION

PRESSURE AND BLOATING

Lemon Creme

*compare to the active ingredients of Maalox Advanced Maximum Strength

12 FL OZ (355 mL)

Maximum Strength Antacid Antigas
Maximum Strength Antacid Antigas

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5725-14ML - Milliliter0904-5725bdefd943-80db-4a30-a73c-f839d6f87baf12013-09-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-822868788-8228-3
0904-5725

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GLYCERINPDC6A3C0OXIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f454cd24-1fff-43b6-ade6-1bc8aa8f431b8763dfa4-ff87-4513-929d-0be2e56f518d2023-12-21WarningsExact identifier
spl set id: 8763dfa4-ff87-4513-929d-0be2e56f518d
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEMAJOR Pharmaceuticals Inc.536b143d-a1d7-4972-a90b-248e419370702023-11-02WarningsExact identifier
ndc (product): 0904-5725

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.