Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension

Manufacturer
Major Pharmaceuticals
Effective date
2025-09-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:34:41

Label at a glance#

ProductAluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE, UNSPECIFIED
Label structure10 sections

Dosage and administration

1,200-1,200-120 mg/30 mL  age dose Adults and children 12 years and older 30mL, not more than 120 mL in 24 hrs  Children under 6 years of age Do not use unless directed by a doctor 2,400-2,400-240 mg/30 mL  age dose Adults and children 12 years and older 30mL, not more than 60 mL in 24 hrs Children under 6 years of age Do not use unless directed by a doctor

Storage and handling

1,200-1,200-120 mg/30 mL • each 30 mL contains magnesium 510 mg and sodium 18 mg • protect from freezing • store at 20° to 25°C (68° to 77°F). • do not use if lid seal is open or damaged • retain this insert for full product information 2,400-2,400-240 mg/30 mL • each 30 mL contains magnesium 990 mg, sodium 30 mg • store at 20° to 25°C (68° to 77°F).  • protect from freezing • do not use if lid seal is open or dam...

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

1,200-1,200-120 mg/30 mL

Active ingredients (in each 30 mL)                                               Purpose 

Aluminum hydroxide 1,200 mg (equivalent to dried gel, USP)..............Antacid
Magnesium hydroxide 1,200 mg......................................................Antacid
Simethicone 120 mg......................................................................Antigas

2,400-2,400-240 mg/30 mL

Active ingredient (in each 30 mL)                                               Purpose
Aluminum hydroxide 2,400 mg (equivalent to dried gel, USP)..............Antacid
Magnesium hydroxide 2,400 mg......................................................Antacid
Simethicone 240 mg......................................................................Antigas

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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 aretaking another medication. This product may interact with certain medications.

OTC - STOP USE SECTION

Stop use and ask a doctor ifsymptoms 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 out of reach of children.

Directions • shake well before use

DOSAGE & ADMINISTRATION SECTION

1,200-1,200-120 mg/30 mL

 age

dose

Adults and children 12 years and older

30mL, not more than 120 mL in 24 hrs 

Children under 6 years of age

Do not use unless directed by a doctor

2,400-2,400-240 mg/30 mL

 age

dose

Adults and children 12 years and older

30mL, not more than 60 mL in 24 hrs

Children under 6 years of age

Do not use unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

1,200-1,200-120 mg/30 mL

  • each 30 mL containsmagnesium 510 mg and sodium 18 mg
  • protect from freezing
  • store at 20° to 25°C (68° to 77°F).
  • do not use if lid seal is open or damaged
  • retain this insert for full product information

2,400-2,400-240 mg/30 mL

  • each 30 mL containsmagnesium 990 mg, sodium 30 mg
  • store at 20° to 25°C (68° to 77°F). 
  • protect from freezing
  • do not use if lid seal is open or damaged
  • retain this insert for full product information

INACTIVE INGREDIENT SECTION

Inactive ingredientsbenzyl alcohol, butylparaben, carboxy-methycellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

OTC - QUESTIONS SECTION

Questions or comments?(855) 879-4368

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

(800) 616-2471

Rev. 06/23

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7325-62

Each 30 mL Contains:

Magnesium hydroxide 1,200 mg

Aluminum hydroxide 1,200 mg 

Simethicone 120 mg

SHAKE WELL

Delivers 30 mL • See insert

For Institutional Use Only 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7326-62

Each 30 mL Contains:

Magnesium hydroxide 2,400 mg

Aluminum hydroxide 2,400 mg 

Simethicone 240 mg

SHAKE WELL

Delivers 30 mL • See insert

For Institutional Use Only 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

aampdp
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7325-62ML - Milliliter0904-7325d0d17562-1644-4729-a778-15e9c52dab2912023-09-05
0904-7325-73ML - Milliliter0904-73259e6bd2ab-3721-4ce5-81c8-727835661d0f12023-09-05
0904-7326-62ML - Milliliter0904-73261138210c-ebe8-4d6c-b485-928dba8e4ec712023-09-05
0904-7326-73ML - Milliliter0904-73262101f00b-de69-424a-adeb-d283f2342f5b12023-09-05

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-73250904-7325-62, 0904-7325-73
0904-73260904-7326-62, 0904-7326-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c4f8e03f-05b6-4a4b-a737-b797d1449a7b0cab04e3-8b95-48bd-8bd0-2f7fef4addc02025-09-04WarningsExact identifier
spl id: c4f8e03f-05b6-4a4b-a737-b797d1449a7b
spl set id: 0cab04e3-8b95-48bd-8bd0-2f7fef4addc0

Reported adverse events (FAERS/openFDA)#

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