Magnesium Hydroxide, Aluminum Hydroxide, And Simethicone Suspension

SPL v1

SPL

SPL Set ID 2faf291e-1d62-412a-a05e-e992cb7def6a

Route

ORAL

Published

Effective Date 2025-01-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Aluminum Hydroxide (200 mg) Hydroxide Ion (20 mg) Dimethicone, Unspecified

Inactive Ingredients

Butylparaben Propylparaben Hypromellose 2910 (4000 Mpa.s) Propylene Glycol Sorbitol Saccharin Sodium Peppermint Oil Water

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Aluminum hydroxide (equiv. to dried gel, USP) 1200 mg Antacid Magnesium hydroxide 1200 mg Antacid Simethicone 120 mg Antigas

Purpose

Antacid/Antigas

Medication Information

Purpose

Antacid/Antigas

Description

Aluminum hydroxide (equiv. to dried gel, USP) 1200 mg Antacid Magnesium hydroxide 1200 mg Antacid Simethicone 120 mg Antigas

Uses

for the relief of:

acid indigestion
heartburn
sour stomach
upset stomach due to these symptoms
pressure and bloating commonly referred to as gas

Warnings

Do not take more than 4 unit dose cups (120 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.

Directions

shake well before using
do not take more than 4 unit dose cups (120 mL) in 24 hours or use the maximum dosage for more than 2 weeks

adults and children 12 years and older	Take 30 mL, one unit dose cup, between meals and at bedtime, or as directed by a doctor.
children under 12 years	consult a physician

Distributed By:

American Health Packaging

Columbus, OH 43217

R01/25

Other Information

each 30 mL contains: magnesium 498 mg, sodium 8.04 mg
Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].
protect from freezing
White colored, peppermint flavored liquid supplied in the following oral dosage form:
30 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐877‐76

Active Ingredients

Aluminum hydroxide (equiv. to dried gel, USP) 1200 mg	Antacid
Magnesium hydroxide 1200 mg	Antacid
Simethicone 120 mg	Antigas

Inactive Ingredients

Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium , and sorbitol solution.

Questions Or Comments?

Call 1-800-845-8210

DO NOT USE IF SEAL IS BROKEN.

Stop Use and Ask A Doctor If

symptoms last more than 2 weeks.

Ask A Doctor Before Use If You Have

kidney disease
a magnesium-restricted diet

Principal Display Panel – Tray Label

Case NDC 60687-877-76/Cup NDC 60687-877-45

Magnesium Hydroxide,

Aluminum Hydroxide, and

Simethicone Suspension

Antacid/Antigas

1200 mg/1200 mg/120 mg per 30 mL

Sugar Free

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Protect from freezing.

For Institutional Use Only

T1761C300125 R01/25

Ask A Doctor Or Pharmacist Before Use If You Are

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

Principal Display Panel – Cup – 1200 Mg/1200 Mg/120 Mg 30 Ml

NDC 60687- 877-45

Magnesium Hydroxide,

Aluminum Hydroxide, and

Simethicone Suspension

Antacid/Anti-Gas

1200 mg/1200 mg/120 mg per 30 mL

Sugar Free

Delivers 30 mL

SHAKE WELL/Protect from freezing

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F1761C300125

Structured Label Content

Uses

for the relief of:

acid indigestion
heartburn
sour stomach
upset stomach due to these symptoms
pressure and bloating commonly referred to as gas

Purpose

Antacid/Antigas

Warnings

Do not take more than 4 unit dose cups (120 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.

Directions

shake well before using
do not take more than 4 unit dose cups (120 mL) in 24 hours or use the maximum dosage for more than 2 weeks

adults and children 12 years and older	Take 30 mL, one unit dose cup, between meals and at bedtime, or as directed by a doctor.
children under 12 years	consult a physician

Distributed By: (Distributed by:)

American Health Packaging

Columbus, OH 43217

R01/25

Other Information (Other information)

each 30 mL contains: magnesium 498 mg, sodium 8.04 mg
Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].
protect from freezing
White colored, peppermint flavored liquid supplied in the following oral dosage form:
30 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐877‐76

Active Ingredients (Active ingredients)

Aluminum hydroxide (equiv. to dried gel, USP) 1200 mg	Antacid
Magnesium hydroxide 1200 mg	Antacid
Simethicone 120 mg	Antigas

Inactive Ingredients (Inactive ingredients)

Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium , and sorbitol solution.

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210

DO NOT USE IF SEAL IS BROKEN.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms last more than 2 weeks.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney disease
a magnesium-restricted diet

Principal Display Panel – Tray Label

Case NDC 60687-877-76/Cup NDC 60687-877-45

Magnesium Hydroxide,

Aluminum Hydroxide, and

Simethicone Suspension

Antacid/Antigas

1200 mg/1200 mg/120 mg per 30 mL

Sugar Free

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Protect from freezing.

For Institutional Use Only

T1761C300125 R01/25

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

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

Principal Display Panel – Cup – 1200 Mg/1200 Mg/120 Mg 30 Ml (Principal Display Panel – Cup – 1200 mg/1200 mg/120 mg 30 mL)

NDC 60687- 877-45

Magnesium Hydroxide,

Aluminum Hydroxide, and

Simethicone Suspension

Antacid/Anti-Gas

1200 mg/1200 mg/120 mg per 30 mL

Sugar Free

Delivers 30 mL

SHAKE WELL/Protect from freezing

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F1761C300125

Advanced Ingredient Data

[{"name": "BUTYLPARABEN", "unii": "3QPI1U3FV8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (4000 MPA.S)", "unii": "RN3152OP35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM HYDROXIDE", "unii": "5QB0T2IUN0", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXIDE ION", "unii": "9159UV381P", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DIMETHICONE, UNSPECIFIED", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of: acid indigestion heartburn sour stomach upset stomach due to these symptoms pressure and bloating commonly referred to as gas", "Purpose": "Antacid/Antigas", "Warnings": "Do not take more than 4 unit dose cups (120 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.", "Directions": "shake well before using do not take more than 4 unit dose cups (120 mL) in 24 hours or use the maximum dosage for more than 2 weeks adults and children 12 years and older Take 30 mL, one unit dose cup, between meals and at bedtime, or as directed by a doctor. children under 12 years consult a physician", "Distributed by:": "American Health Packaging Columbus, OH 43217 R01/25", "Other information": "each 30 mL contains: magnesium 498 mg, sodium 8.04 mg Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. protect from freezing White colored, peppermint flavored liquid supplied in the following oral dosage form: 30 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐877‐76", "Active ingredients": "Aluminum hydroxide (equiv. to dried gel, USP) 1200 mg Antacid Magnesium hydroxide 1200 mg Antacid Simethicone 120 mg Antigas", "Inactive ingredients": "Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium , and sorbitol solution.", "Questions or comments?": "Call 1-800-845-8210 DO NOT USE IF SEAL IS BROKEN.", "Stop use and ask a doctor if": "symptoms last more than 2 weeks.", "Ask a doctor before use if you have": "kidney disease a magnesium-restricted diet", "Principal Display Panel – Tray Label": "Case NDC 60687-877-76/Cup NDC 60687-877-45 Magnesium Hydroxide, Aluminum Hydroxide, and Simethicone Suspension Antacid/Antigas 1200 mg/1200 mg/120 mg per 30 mL Sugar Free SHAKE WELL USUAL DOSAGE: See attached Drug Facts Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing. For Institutional Use Only T1761C300125 R01/25", "Ask a doctor or pharmacist before use if you are": "presently taking a prescription drug. Antacids may interact with certain prescription drugs.", "Principal Display Panel – Cup – 1200 mg/1200 mg/120 mg 30 mL": "NDC 60687- 877 -45 Magnesium Hydroxide, Aluminum Hydroxide, and Simethicone Suspension Antacid/Anti-Gas 1200 mg/1200 mg/120 mg per 30 mL Sugar Free Delivers 30 mL SHAKE WELL/Protect from freezing See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F1761C300125"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:12.275105 · Updated: 2026-03-14T23:08:50.768383