Aluminum Hydroxide, Magnesium Hydroxide And Simethicone 1,200-1,200-120 Mg/30 Ml, 2,400-2,400-240 Mg/30 Ml

Aluminum Hydroxide, Magnesium Hydroxide And Simethicone 1,200-1,200-120 Mg/30 Ml, 2,400-2,400-240 Mg/30 Ml
SPL v3
SPL
SPL Set ID 982129d4-3cbf-4793-a861-d6c8f34bedc3
Route
ORAL
Published
Effective Date 2025-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-05
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. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Section 50566-9

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

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs

Section 50569-3

Ask a doctor before use if you have

• kidney disease

• a magnesium restricted diet

Section 51727-6

1,200-1,200-120 mg/30 mL / 2,400-2,400-240 mg/30 mL

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

Section 53413-1

NDC Information -



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

Each 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 1,200 mg, Magnesium hydroxide 1,200 mg and Simethicone 120 mg and is supplied in the following oral dosage forms:

NDC 57237-316-03 unit dose cup 30 mL

NDC 57237-316-31 (100 x 30 mL) unit-dose cups



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

Each 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 2,400 mg, Magnesium hydroxide 2,400 mg and Simethicone 240 mg and is supplied in the following oral dosage forms:

NDC 57237-324-03 unit dose cup 30 mL

NDC 57237-324-31 (100 x 30 mL) unit-dose cups

Section 53414-9

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

Section 55105-1

Drug Facts

Warnings

Other Information

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

•   each 30 mL (unit dose) contains magnesium 510 mg and sodium 18 mg

•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   protect from freezing

•   do not use if lid is torn or broke

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

•   each 30 mL (unit dose) contains magnesium 990 mg and sodium 6 mg

•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   protect from freezing

•   do not use if lid is torn or broken

Directions • Shake Well Before Use

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

•   Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks

 age dose
Adults and children over 12 years of age Take 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour period
Children under 12 years of age Ask a doctor 

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

•   Do not use more than 2 unit dose (60 mL) in a 24 hour period or use the maximum dose for more than 2 weeks

 age dose
Adults and children over 12 years of age Take 30 mL, one unit dose, one to two times daily or as directed by a doctor. Do not exceed 2 x 30 mL unit dose (60 mL) in a 24 hour period
Children under 12 years of age Ask a doctor

Package Label.principal Display Panel

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

Case Label NDC 57237-316-31

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

Lid Label NDC 57237-316-03

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

Case Label NDC 57237-324-31

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

Lid Label NDC 57237-324-03

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. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Section 50566-9 (50566-9)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• kidney disease

• a magnesium restricted diet

Section 51727-6 (51727-6)

1,200-1,200-120 mg/30 mL / 2,400-2,400-240 mg/30 mL

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

Section 53413-1 (53413-1)

NDC Information -



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

Each 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 1,200 mg, Magnesium hydroxide 1,200 mg and Simethicone 120 mg and is supplied in the following oral dosage forms:

NDC 57237-316-03 unit dose cup 30 mL

NDC 57237-316-31 (100 x 30 mL) unit-dose cups



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

Each 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 2,400 mg, Magnesium hydroxide 2,400 mg and Simethicone 240 mg and is supplied in the following oral dosage forms:

NDC 57237-324-03 unit dose cup 30 mL

NDC 57237-324-31 (100 x 30 mL) unit-dose cups

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Drug Facts

Warnings

Other Information (Other information)

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

•   each 30 mL (unit dose) contains magnesium 510 mg and sodium 18 mg

•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   protect from freezing

•   do not use if lid is torn or broke

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

•   each 30 mL (unit dose) contains magnesium 990 mg and sodium 6 mg

•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   protect from freezing

•   do not use if lid is torn or broken

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

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

•   Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks

 age dose
Adults and children over 12 years of age Take 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour period
Children under 12 years of age Ask a doctor 

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

•   Do not use more than 2 unit dose (60 mL) in a 24 hour period or use the maximum dose for more than 2 weeks

 age dose
Adults and children over 12 years of age Take 30 mL, one unit dose, one to two times daily or as directed by a doctor. Do not exceed 2 x 30 mL unit dose (60 mL) in a 24 hour period
Children under 12 years of age Ask a doctor

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

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

Case Label NDC 57237-316-31

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

Lid Label NDC 57237-316-03

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

Case Label NDC 57237-324-31

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

Lid Label NDC 57237-324-03

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:26.976723 · Updated: 2026-03-14T23:09:13.832086