FDA.reportPublic FDA data

aluminum hydroxide, magnesium hydroxide, simethicone

Manufacturer
LLC Federal Solutions | Safecor Health, LLC
Effective date
2013-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:40:02

Label at a glance#

Productaluminum hydroxide, magnesium hydroxide, simethicone
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

OTC - PURPOSE SECTION

Purpose

Antacid

Antacid

Antigas

INDICATIONS & USAGE SECTION

Uses

For the relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • the symptoms of gas associated with acid indigestion, heartburn, and sour stomach

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children.

When using this product you may get constipated

DOSAGE & ADMINISTRATION SECTION

Directions

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

OTHER SAFETY INFORMATION

Other information

  • each 5 mL teaspoonful contains: magnesium 165 mg, sodium 1 mg
  • store at room temperature
  • keep tightly closed

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzyl alcohol, butylparaben, caramel, color, carboxymethylcellulose sodium, D&C yellow #10, flavor, purified water, saccharin sodium, sorbitol solution

SPL UNCLASSIFIED SECTION

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801

Distributed by: LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



———PRINCIPAL DISPLAY PANEL———
NDC: 24451-725-30
DELIVERS 30 mL CONTAINING:
ALUMINUM HYDROXIDE 2400 mg
MAGNESIUM HYDROXIDE 2400 mg
SIMETHICONE 240 mg
(MINTOX)
MAXIMUM STRENGTH
ORAL SUSPENSION
ANTACID / ANTIGAS
SHAKE WELL BEFORE USE
LEMON CREME
Exp: 00/00/00   Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

product labelproduct label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24451-725-302020-01-07C16284748780-19855d018-dad2-cd31-e053-dbdaa90ab51afc3c5c56-772f-44f8-b42f-88909ad68a5e
24451-725-302019-11-27C16284748780-19855d018-dad2-cd31-e053-dbdaa90ab51afc3c5c56-772f-44f8-b42f-88909ad68a5e

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN01
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004S1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN01
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
CARAMELINACTIVE INGREDIENTT9D99G2B1R1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3111
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24451-72524451-725-30
0904-5725

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE92RU3N3Y1OACTIB
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
CARAMELT9D99G2B1RIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSUSPENSION / ORAL20 mg/5mlExact identifier — unii+route+dosage form
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+route+dosage form
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii+route+dosage form
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route+dosage form

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
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEMAJOR Pharmaceuticals Inc.536b143d-a1d7-4972-a90b-248e419370702023-11-02WarningsExact identifier
ndc (product): 0904-5725
182d5565-8aa9-493e-a24e-712433bc9302fc3c5c56-772f-44f8-b42f-88909ad68a5e2013-08-12WarningsExact identifier
spl id: 182d5565-8aa9-493e-a24e-712433bc9302
spl set id: fc3c5c56-772f-44f8-b42f-88909ad68a5e

Reported adverse events (FAERS/openFDA)#

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