Magnesium Hydroxide, Aluminum Hydroxide, And Simethicone Suspension

Magnesium Hydroxide, Aluminum Hydroxide, And Simethicone Suspension
SPL v2
SPL
SPL Set ID 23539e7e-a723-460f-892f-dac5bbbb9b16
Route
ORAL
Published
Effective Date 2025-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (400 mg) Hydroxide Ion (40 mg) Dimethicone, Unspecified
Inactive Ingredients
Butylparaben Propylparaben Hypromellose 2910 (4000 Mpa.s) Propylene Glycol Sorbitol Saccharin Sodium Peppermint Oil Cyclomethicone 4 Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-15

Description

Aluminum hydroxide (equiv. to dried gel, USP) 2400 mg Antacid Magnesium hydroxide 2400 mg Antacid Simethicone 240 mg Antigas

Purpose

Antacid/Antigas


Medication Information

Purpose

Antacid/Antigas

Description

Aluminum hydroxide (equiv. to dried gel, USP) 2400 mg Antacid Magnesium hydroxide 2400 mg Antacid Simethicone 240 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 2 unit dose cups (60 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 2 unit dose cups (60 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, one to two times daily, 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 1,002 mg, sodium 13.44 mg
  • Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
  • protect from freezing
  • White colored, cherry flavored liquid supplied in the following oral dosage form:
  • 30 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐888‐76
Active Ingredients

Aluminum hydroxide (equiv. to dried gel, USP) 2400 mg

Antacid

Magnesium hydroxide 2400 mg

Antacid

Simethicone 240 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 60687-888-76/Cup NDC 60687-888-45

Magnesium Hydroxide,

Aluminum Hydroxide, and

Simethicone Suspension

Antacid/Antigas

2400 mg/2400 mg/240 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

T1762C300125            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 – 2400 Mg/2400 Mg/240 Mg 30 Ml

NDC 60687- 888-45

Magnesium Hydroxide,

Aluminum Hydroxide, and

Simethicone Suspension

Antacid/Anti-Gas

2400 mg/2400 mg/240 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

F1762C300125


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 2 unit dose cups (60 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 2 unit dose cups (60 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, one to two times daily, 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 1,002 mg, sodium 13.44 mg
  • Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
  • protect from freezing
  • White colored, cherry flavored liquid supplied in the following oral dosage form:
  • 30 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐888‐76
Active Ingredients (Active ingredients)

Aluminum hydroxide (equiv. to dried gel, USP) 2400 mg

Antacid

Magnesium hydroxide 2400 mg

Antacid

Simethicone 240 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 60687-888-76/Cup NDC 60687-888-45

Magnesium Hydroxide,

Aluminum Hydroxide, and

Simethicone Suspension

Antacid/Antigas

2400 mg/2400 mg/240 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

T1762C300125            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 – 2400 Mg/2400 Mg/240 Mg 30 Ml (Principal Display Panel – Cup – 2400 mg/2400 mg/240 mg 30 mL)

NDC 60687- 888-45

Magnesium Hydroxide,

Aluminum Hydroxide, and

Simethicone Suspension

Antacid/Anti-Gas

2400 mg/2400 mg/240 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

F1762C300125


Advanced Ingredient Data


Raw Label Data

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