Indications and uses
relieves heartburn sour stomach acid indigestion the symptoms referred to as gas
REGULAR STRENGTH ANTACID
- Manufacturer
- AMERISOURCEBERGEN DRUG CORPORATION | GCP Laboratories
- Effective date
- 2023-11-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:59:18
Label at a glance#
ProductREGULAR STRENGTH ANTACID
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure9 sections
Dosage and administration
shake well before use adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks children under 12 years: ask a doctor
Storage and handling
each 10 mL dose contains: magnesium 165 mg, sodium 6 mg store at room temperature protect from freezing keep tightly closed
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 10 mL dose)
Aluminum hydroxide 400 mg (equivalent to dried gel, USP)
Magnesium hydroxide 400 mg
Simethicone 40mg
Purposes
Antacid
Antigas
Uses
relieves
- heartburn
- sour stomach
- acid indigestion
- the symptoms referred to as gas
Warnings
Do not take more than 120 mL (12 doses) in a 24 hour period or use
the maximum dosage for more than 2 weeks.
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.
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Directions
- shake well before use
- adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
- do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
- children under 12 years: ask a doctor
Other information
- each 10 mL dose contains: magnesium 165 mg, sodium 6 mg
- store at room temperature
- protect from freezing
- keep tightly closed
Inactive ingredients
benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution
Questions or comments?
1-800-540-3765
package Label
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 | 4 |
| 307746 | aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension | SCD | 4 |
| 307746 | aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral Suspension | SY | 4 |
| 307746 | aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral Suspension | SY | 4 |
| 307746 | aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral Suspension | SY | 4 |
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 |
|---|---|---|---|---|---|---|
| 46122-433-40 | REGULAR STRENGTH ANTACID | 355 mL in 1 BOTTLE | LIQUID | 355 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 46122-433 | REGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) LIQUID [AMERISOURCEBERGEN DRUG CORPORATION] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231108_5e1eed65-0d4c-2d02-e053-2991aa0a95c1.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 46122-433-40 | ML - Milliliter | 46122-433 | 490d1f53-ff12-4299-940c-c6a425b1d2e8 | 1 | 2018-04-19 |
Products#
Every source-derived product name is available through these pages.
- REGULAR STRENGTH ANTACID
- aluminum hydroxide, magnesium hydroxide, dimethicone
- BENZYL ALCOHOL
- BUTYLPARABEN
- HYDROXYETHYL CELLULOSE, UNSPECIFIED
- PROPYLPARABEN
- WATER
- SACCHARIN SODIUM
- SACCHARIN
- SORBITOL SOLUTION
- ALUMINUM HYDROXIDE
- MAGNESIUM HYDROXIDE
- MAGNESIUM CATION
- HYDROXIDE ION
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 46122-433 | 46122-433-40 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| HYDROXYETHYL CELLULOSE, UNSPECIFIED | T4V6TWG28D | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| ALUMINUM HYDROXIDE | 5QB0T2IUN0 | ACTIB |
| MAGNESIUM HYDROXIDE | NBZ3QY004S | ACTIB |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
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 |
|---|---|---|---|---|---|---|
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | AMERISOURCEBERGEN DRUG CORPORATION | 5e1eed65-0d4c-2d02-e053-2991aa0a95c1 | 2023-11-07 | Warnings | 46122-433-40 46122-433 46122043340 0993837b-838b-4a83-e063-6394a90a437e 5e1eed65-0d4c-2d02-e053-2991aa0a95c1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.