Active Ingredients And Purpose
OTC - PURPOSE SECTION
Drug Facts
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone
- Manufacturer
- Everpharm LLC
- Effective date
- 2025-01-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:53:01
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Uses relieves • heartburn • sour stomach • acid indigestion • the symptoms referred to as gas
Warnings
Warnings
Directions And Dosage
Directions • shake well before use
1,200-1,200-120 mg/30 mL • Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks age dose Adults and children over 12 years of age Take 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour period Children under 12 years of age Ask a doctor 2,400-2,400-240 mg/30 mL • Do not use more than 2 unit dose (60 mL) in a 24 hour period or use the maximum dose for more than 2 weeks age dose Adults and children over 12 years of age Take 30 mL, one unit dose, one to two times daily or as directed by a doctor. Do not exceed 2 x 30 mL unit dose (60 mL) in a 24 hour period Children under 12 years of age Ask a doctor
Other Label Information
Other information
1,200-1,200-120 mg/30 mL • each 30 mL (unit dose) contains magnesium 510 mg and sodium 18 mg • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • protect from freezing • do not use if lid is torn or broke 2,400-2,400-240 mg/30 mL • each 30 mL (unit dose) contains magnesium 990 mg and sodium 6 mg • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • protect from freezing • do not use if lid is torn or broken
INACTIVE INGREDIENT SECTION
Inactive ingredients benzyl alcohol, butylparaben, carboxy-methycellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution
OTC - QUESTIONS SECTION
Questions or comments? Call (866) 838-3774
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
EverPharm NDC 84415-017-01 Aluminum Hydroxide Magnesium Hydroxide and Simethicone Antacid & Antigas 1,200-1,200-120 mg/30 mL • Sugar Free For Institutional Use Only 100 x 30 mL Unit-Dose Cups
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307746 | aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral Suspension | PSN | 1 |
| 237870 | aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral Suspension | PSN | 1 |
| 307746 | aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension | SCD | 1 |
| 237870 | aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension | SCD | 1 |
| 307746 | aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral Suspension | SY | 1 |
| 307746 | aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral Suspension | SY | 1 |
| 237870 | aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral Suspension | SY | 1 |
| 237870 | aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral Suspension | SY | 1 |
| 307746 | aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral Suspension | SY | 1 |
| 237870 | aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral Suspension | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84415-010-01 | Aluminum Hydroxide, Magnesium Hydroxide and Simethicone | 30 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 30 | 1 | |
| 84415-010-01 | Aluminum Hydroxide, Magnesium Hydroxide and Simethicone | 100 in 1 BOX, UNIT-DOSE | SUSPENSION | 100 | 1 | |
| 84415-017-01 | Aluminum Hydroxide, Magnesium Hydroxide and Simethicone | 100 in 1 BOX, UNIT-DOSE | SUSPENSION | 100 | 1 | |
| 84415-017-01 | Aluminum Hydroxide, Magnesium Hydroxide and Simethicone | 30 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 84415-010 | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE) SUSPENSION [EVERPHARM LLC] | 1 | Current NDC, 2 package rows | 20250119_2bda74cb-e77d-46bb-e063-6394a90af580.zip |
| 84415-017 | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE) SUSPENSION [EVERPHARM LLC] | 1 | Current NDC, 2 package rows | 20250119_2bda74cb-e77d-46bb-e063-6394a90af580.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 84415-017-01 | ML - Milliliter | 84415-017 | a84d8bd3-132f-48f6-bdd9-0ddd1bfa5a79 | 1 | 2025-05-14 |
| 84415-010-01 | ML - Milliliter | 84415-010 | b4e1b368-6bce-489d-9a95-1be38ef15e1c | 1 | 2025-05-14 |
Products#
- Aluminum Hydroxide, Magnesium Hydroxide and Simethicone
- Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
- MAGNESIUM CATION
- HYDROXIDE ION
NDC Codes#
Ingredients#
Complete SPL Sections#
OTC - PURPOSE SECTION
Drug Facts
INDICATIONS & USAGE SECTION
Uses relieves • heartburn • sour stomach • acid indigestion • the symptoms referred to as gas
Warnings
Directions • shake well before use
1,200-1,200-120 mg/30 mL • Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks age dose Adults and children over 12 years of age Take 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour period Children under 12 years of age Ask a doctor 2,400-2,400-240 mg/30 mL • Do not use more than 2 unit dose (60 mL) in a 24 hour period or use the maximum dose for more than 2 weeks age dose Adults and children over 12 years of age Take 30 mL, one unit dose, one to two times daily or as directed by a doctor. Do not exceed 2 x 30 mL unit dose (60 mL) in a 24 hour period Children under 12 years of age Ask a doctor
Other information
1,200-1,200-120 mg/30 mL • each 30 mL (unit dose) contains magnesium 510 mg and sodium 18 mg • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • protect from freezing • do not use if lid is torn or broke 2,400-2,400-240 mg/30 mL • each 30 mL (unit dose) contains magnesium 990 mg and sodium 6 mg • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • protect from freezing • do not use if lid is torn or broken
INACTIVE INGREDIENT SECTION
Inactive ingredients benzyl alcohol, butylparaben, carboxy-methycellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution
OTC - QUESTIONS SECTION
Questions or comments? Call (866) 838-3774
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
EverPharm NDC 84415-017-01 Aluminum Hydroxide Magnesium Hydroxide and Simethicone Antacid & Antigas 1,200-1,200-120 mg/30 mL • Sugar Free For Institutional Use Only 100 x 30 mL Unit-Dose Cups
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
EverPharm NDC 84415-010-01 Aluminum Hydroxide Magnesium Hydroxide and Simethicone Antacid & Antigas 2,400-2,400-240 mg/30 mL • Sugar Free For Institutional Use Only 100 x 30 mL Unit-Dose Cups