Aluminum Hydroxide, Magnesium Hydroxide, And Simethicone Suspension

Aluminum Hydroxide, Magnesium Hydroxide, And Simethicone Suspension
SPL v10
SPL
SPL Set ID 1bc90fa7-fcce-4a9b-862f-f30ab602ecab
Route
ORAL
Published
Effective Date 2025-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (1200 mg) Hydroxide Ion (120 mg) Dimethicone
Inactive Ingredients
Butylparaben Propylparaben Propylene Glycol Sorbitol Saccharin Sodium Peppermint Oil Water Hydroxypropyl Methylcellulose

Identifiers & Packaging

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

Description

Active ingredients                                                                                 Purpose (in each 5 mL = 1 teaspoonful) Aluminum hydroxide (equiv. to dried gel, USP) 200 mg .......................... Antacid Magnesium hydroxide 200 mg .............................................................. Antacid Simethicone 20 mg ............................................................................... Antigas


Medication Information

Indications and Usage

Uses for the relief of:

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

Active ingredients                                                                                 Purpose (in each 5 mL = 1 teaspoonful) Aluminum hydroxide (equiv. to dried gel, USP) 200 mg .......................... Antacid Magnesium hydroxide 200 mg .............................................................. Antacid Simethicone 20 mg ............................................................................... Antigas

Section 42229-5

R02/25

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

Inactive ingredients butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium, and sorbitol solution.

Warnings

Do not take more than 16 teaspoonfuls 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 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
adults and children 12 years and older take 2 to 4 teaspoonfuls four times a day or as directed by a physician
children under 12 years consult a physician
Drug Facts

Active ingredients                                                                                 Purpose

(in each 5 mL = 1 teaspoonful)

Aluminum hydroxide (equiv. to dried gel, USP) 200 mg .......................... Antacid

Magnesium hydroxide 200 mg .............................................................. Antacid

Simethicone 20 mg ............................................................................... Antigas

Other Information
  • each 5 mL contains: magnesium 83 mg, sodium 1.34 mg
  • store at controlled room temperature 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:

NDC 0904-7557-62:  30 mL unit dose cup, in a tray of ten cups.

Ask A Doctor Before Use If You Have
  • kidney disease
  • a magnesium-restricted diet
Principal Display Panel 30 Ml Unit Dose Cup Lidding Label

MAJOR®

NDC 0904-7557-62

Each 30 mL Contains:

Magnesium Hydroxide     1200 mg

Aluminum Hydroxide        1200 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 for the relief of:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach due to these symptoms
  • pressure and bloating commonly referred to as gas
Section 42229-5 (42229-5)

R02/25

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 51727-6 (51727-6)

Inactive ingredients butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium, and sorbitol solution.

Warnings

Do not take more than 16 teaspoonfuls 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 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
adults and children 12 years and older take 2 to 4 teaspoonfuls four times a day or as directed by a physician
children under 12 years consult a physician
Drug Facts

Active ingredients                                                                                 Purpose

(in each 5 mL = 1 teaspoonful)

Aluminum hydroxide (equiv. to dried gel, USP) 200 mg .......................... Antacid

Magnesium hydroxide 200 mg .............................................................. Antacid

Simethicone 20 mg ............................................................................... Antigas

Other Information (Other information)
  • each 5 mL contains: magnesium 83 mg, sodium 1.34 mg
  • store at controlled room temperature 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:

NDC 0904-7557-62:  30 mL unit dose cup, in a tray of ten cups.

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 30 Ml Unit Dose Cup Lidding Label (PRINCIPAL DISPLAY PANEL - 30 mL Unit-Dose Cup Lidding Label)

MAJOR®

NDC 0904-7557-62

Each 30 mL Contains:

Magnesium Hydroxide     1200 mg

Aluminum Hydroxide        1200 mg

Simethicone                       120 mg

SHAKE WELL

Delivers 30 mL • See insert

For Institutional Use Only

MAJOR ®  PHARMACEUTICALS

Indianapolis, IN 46268

 

  

 


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