Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE MAJOR PHARMACEUTICALS FDA Approved Uses relieves • heartburn • sour stomach • acid indigestion • the symptoms referred to as gas

Drug Facts

Composition & Profile

Active Ingredients
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
Inactive Ingredients
Inactive ingredients benzyl alcohol butylparaben carboxy-methycellulose sodium flavor hypromellose microcrystalline cellulose propylparaben purified water saccharin sodium sorbitol solution
Strengths
120 mg/30 ml 30 ml 1200 mg 120 mg 240 mg/30 ml 2400 mg 240 mg
Quantities
30 ml
Treats Conditions
Uses Relieves Heartburn Sour Stomach Acid Indigestion The Symptoms Referred To As Gas

Identifiers & Packaging

Container Type UNKNOWN
UPC
0309047326624 0309047325627
UNII
5QB0T2IUN0 92RU3N3Y1O NBZ3QY004S
Packaging

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 aapdp; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 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 aampdp

Package Descriptions
  • 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 aapdp
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 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 aampdp

Overview

Uses relieves • heartburn • sour stomach • acid indigestion • the symptoms referred to as gas

Indications & Usage

Uses relieves • heartburn • sour stomach • acid indigestion • the symptoms referred to as gas

Dosage & Administration

Directions • shake well before use 1,200-1,200-120 mg/30 mL age dose Adults and children 12 years and older 30mL, not more than 120 mL in 24 hrs Children under 6 years of age Do not use unless directed by a doctor 2,400-2,400-240 mg/30 mL age dose Adults and children 12 years and older 30mL, not more than 60 mL in 24 hrs Children under 6 years of age Do not use unless directed by a doctor

Warnings & Precautions
Warnings Ask a doctor before use if you have • kidney disease • a magnesium restricted diet Ask a doctor or pharmacist before use if you are taking another medication. This product may interact with certain medications. Stop use and ask a doctor if symptoms last more than 2 weeks If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
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

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other information 1,200-1,200-120 mg/30 mL • each 30 mL contains magnesium 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 contains magnesium 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

Questions

Questions or comments? (855) 879-4368 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 Rev. 06/23


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