Aluminum Hydroxide, Magnesium Hydroxide And Simethicone Suspension
FDA Label NDC 0904-7325

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Aluminum Hydroxide, Magnesium Hydroxide And Simethicone Suspension (NDC 0904-7325). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, warnings, directions • shake well before use, other information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Drug Facts

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

Active ingredients (in each 30 mL)                                               Purpose 

Aluminum hydroxide 1,200 mg (equivalent to dried gel, USP)..............Antacid
Magnesium hydroxide 1,200 mg......................................................Antacid
Simethicone 120 mg......................................................................Antigas

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

Active ingredient (in each 30 mL)                                               Purpose
Aluminum hydroxide 2,400 mg (equivalent to dried gel, USP)..............Antacid
Magnesium hydroxide 2,400 mg......................................................Antacid
Simethicone 240 mg......................................................................Antigas

Warnings

Directions • Shake Well Before Use

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

 agedose
Adults and children 12 years and older30mL, not more than 120 mL in 24 hrs 
Children under 6 years of ageDo not use unless directed by a doctor

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

 agedose
Adults and children 12 years and older30mL, not more than 60 mL in 24 hrs
Children under 6 years of ageDo not use unless directed by a doctor

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

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

MAJOR®

NDC 0904-7326-62

Each 30 mL Contains:

Magnesium hydroxide 2,400 mg

Aluminum hydroxide 2,400 mg 

Simethicone 240 mg

SHAKE WELL

Delivers 30 mL • See insert

For Institutional Use Only 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

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