Magnesium Hydroxide/Aluminum Hydroxice/Simethicone
- Manufacturer
- Major Pharmaceuticals | Plastikon Healthcare, LLC
- Effective date
- 2021-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:22:16
Label at a glance#
ProductMagnesium Hydroxide/Aluminum Hydroxice/Simethicone
Active ingredientALUMINUM HYDROXIDE, DIMETHICONE, MAGNESIUM HYDROXIDE
Label structure2 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Magnesium hydroxide, Aluminum hydroxide, Simethicone 1200/1200/120 mg per 30 mL Major Pharmaceutical OTC Monograph
Each 30 mL Contains:
Magnesium Hydroxide1200 mg
Aluminum Hydroxide 1200 mg
Simethicone 120 mg
Delivers 30 mL
Shake Well
See Insert
For Instituional Use Only
MAJOR PHARMACEUTICALS
Livonia, MI 64152
Sugar Free - Dye Free - Alcohol Free
MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL
Directions
- do not exceed the maximum recommended daily dose in a 24 hour period
- shake well before use
- do not use the maximum daily dose for more than 2 weeks
Age (yr) | Dose (mL) |
adults and children 12 years and over | 30 mL, not more than 120 mL in 24 hours |
children under 12 years | ask a doctor |
MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL
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 a presecription drug. Antacids may interact with certain prescription drugs.
___________________________________________________________________
Stop use and ask a doctor if
- you have symptoms that last more than 2 weeks
___________________________________________________________________
If pregnant or breast-feeding, ask a health professional before use.
MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL
Inactive ingredients citric acid, glycerin, microcrystalline cellulose, methyl cellulose, purified water, saccharin sodium, sodium citrate, spearmint oil, xantham gum
MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL
Uses
- acid indigestion
- heartburn
- sour stomach
- upset stomach due to these symptoms
- pressure and bloating commonly referred to as gas
MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL
Active ingredient (in each 30 mL cup)
Magnesium hydroxide USP 1200 mg
Magnesium hydroxide USP 1200 mg
Simethicone 120 mg
MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL
Antacid
Antacid
Antigas
MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL
Other information
- each 30 mL contains: calcium 40 mg, sodium 25 mg, and magnesium 500 mg
- store at 20-25°C (68-77°F)
- protect from excessive moisture
- do not use if lid seal is open or damaged
- sugar free, dye free, alcohol free
- see bottom of cup for lot number and expiration date
MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL
Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL Major Pharmaceutical OTC Monograph
Each 30 mL Contains:
Magnesium Hydroxide 2400 mg
Aluminum Hydroxide 2400 mg
Simethicone 240 mg
Max
Delivers 30 mL
Shake Well
See Insert
For Instituional Use Only
MAJOR PHARMACEUTICALS
Livonia, MI 64152
Sugar Free - Dye Free - Alcohol Free
Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL
Directions
- do not exceed the maximum recommended daily dose in a 24 hour period
- shake well before use
- do not use the maximum daily dose for more than 2 weeks
Age (yr) | Dose (mL) |
adults and children 12 years and over | 30 mL, not more than 60 mL in 24 hrs. |
children under 12 years | ask a doctor |
Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL
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 a prescription drug. Antacids may interact with certain prescription drugs.
___________________________________________________________________
Stop use and ask a doctor if
- you have symptoms that last for more than 2 weeks.
___________________________________________________________________
If pregnant or breast-feeding, ask a health professional before use.
Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL
Inactive ingredients citric acid, glycerin, microcrystalline cellulose, methyl cellulose, purified water, saccharin sodium, sodium citrate, spearmint oil, xanthan gum
Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL
Uses
- acid indigestion
- heartburn
- sour stomach
- upset stomach due to these symptoms
- pressure and bloating commonly referred to as gas
Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL
Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL
Antacid
Antacid
Antigas
Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL
Other information
- each 30 mL contains: calcium 40 mg, sodium 25 mg, and magnesium 1000 mg
- store at 20-25°C (68-77°F) -
- protect from excessive moisture
- do not use if lid seal is open or damaged -
- sugar free, dye free, alcohol free
- see bottom of cup for lot number and expiration date
Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0904-6838-73 | 2022-09-23 | C162847 | 48780-1 | ba0f9c33-5ce8-a910-e053-dadaa90a0b85 | MgOH-Al-OH-Simethicone Major Pharmaceuticals Unit dose OTC Monograph drugs |
| 0904-6839-73 | 2022-09-23 | C162847 | 48780-1 | ba0f9c33-5ce8-a910-e053-dadaa90a0b85 | MgOH-Al-OH-Simethicone Major Pharmaceuticals Unit dose OTC Monograph drugs |
| 0904-6838-73 | 2022-07-29 | C162847 | 48780-1 | ba0f9c33-5ce8-a910-e053-dadaa90a0b85 | MgOH-Al-OH-Simethicone Major Pharmaceuticals Unit dose OTC Monograph drugs |
| 0904-6839-73 | 2022-07-29 | C162847 | 48780-1 | ba0f9c33-5ce8-a910-e053-dadaa90a0b85 | MgOH-Al-OH-Simethicone Major Pharmaceuticals Unit dose OTC Monograph drugs |
| 0904-6838-73 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5ce8-a910-e053-dadaa90a0b85 | MgOH-Al-OH-Simethicone Major Pharmaceuticals Unit dose OTC Monograph drugs |
| 0904-6839-73 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5ce8-a910-e053-dadaa90a0b85 | MgOH-Al-OH-Simethicone Major Pharmaceuticals Unit dose OTC Monograph drugs |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6838-73 | ML - Milliliter | 0904-6838 | b9ad7ff5-4646-451a-a1fb-0ee0dc2a0fae | 1 | 2020-04-20 |
| 0904-6839-73 | ML - Milliliter | 0904-6839 | 87c05ade-8a4d-487c-b24d-1b50225d8b4d | 1 | 2020-04-20 |
Products#
Every source-derived product name is available through these pages.
- Magnesium Hydroxide/Aluminum Hydroxice/Simethicone
- Magnesium Hydroxide,Aluminum Hydroxice,Simethicone
- ALUMINUM HYDROXIDE
- MICROCRYSTALLINE CELLULOSE
- DIMETHICONE
- XANTHAN GUM
- MAGNESIUM HYDROXIDE
- HYDROXIDE ION
- MAGNESIUM CATION
- ANHYDROUS CITRIC ACID
- METHYLCELLULOSE (15 CPS)
- SUCRALOSE
- TRISODIUM CITRATE DIHYDRATE
- GLYCERIN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-6838 | 0904-6838-73 |
| 0904-6839 | 0904-6839-73 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e95f0619-c7e9-4c76-e053-2995a90a2e72 | 97978a75-bf85-ba66-e053-2995a90a3b2d | 2022-09-23 | Warnings | 97978a75-bf85-ba66-e053-2995a90a3b2d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.