Magnesium Hydroxide, Aluminum Hydroxide And Simethicone Suspension 1,200-1,200-120 Mg/30 Ml,

Magnesium Hydroxide, Aluminum Hydroxide And Simethicone Suspension 1,200-1,200-120 Mg/30 Ml,
SPL v3
SPL
SPL Set ID 0cab04e3-8b95-48bd-8bd0-2f7fef4addc0
Route
ORAL
Published
Effective Date 2025-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (1200 mg) Hydroxide Ion (120 mg) Dimethicone, Unspecified (2400 mg)
Inactive Ingredients
Benzyl Alcohol Butylparaben Carboxymethylcellulose Sodium, Unspecified Hypromellose, Unspecified Microcrystalline Cellulose Propylparaben Water Saccharin Sodium Sorbitol Solution

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-08-01 Until 2024-11-30
Description

Drug Facts

Medication Information

Indications and Usage

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

Description

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor ifsymptoms last more than 2 weeks

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking another medication. This product may interact with certain medications.

Section 50569-3

Ask a doctor before use if you have• kidney disease • a magnesium restricted diet

Section 51727-6

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

Section 53413-1

Questions or comments? (855) 879-4368

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

Rev. 06/23

Section 53414-9

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

Section 55105-1

Drug Facts

Other Information

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
Directions • Shake Well Before Use

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
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

Structured Label Content

Indications and Usage (34067-9)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsymptoms last more than 2 weeks

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking another medication. This product may interact with certain medications.

Section 50569-3 (50569-3)

Ask a doctor before use if you have• kidney disease • a magnesium restricted diet

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or comments? (855) 879-4368

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

Rev. 06/23

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Drug Facts

Other Information (Other information)

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
Directions • Shake Well Before Use (Directions • shake well before use)

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
Package Label.principal Display Panel (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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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:55.477901 · Updated: 2026-03-14T23:09:59.416921