ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE suspension

Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone by

Drug Labeling and Warnings

Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PURPOSE

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 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.

Ask a doctor before use if you have

• kidney disease
• a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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

Keep out of reach of children.

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

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.

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

Questions or comments?  Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

R02/25

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

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

 

  

 

INGREDIENTS AND APPEARANCE

ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE 
aluminum hydroxide, magnesium hydroxide, and simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7557
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	1200 mg  in 30 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	1200 mg  in 30 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	120 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7557-73	10 in 1 CASE	07/07/2025
1		10 in 1 TRAY
1	NDC: 0904-7557-62	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	07/07/2025

Labeler - Major Pharmaceuticals (191427277)