Indications and uses
• relieves occasional constipation (irregularity) • usually produces bowel movement in ½ hour to 6 hours
Milk of Magnesia
- Manufacturer
- Rising Pharma Holdings, Inc.
- Effective date
- 2025-07-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:06:25
Label at a glance#
ProductMilk of Magnesia
Active ingredientMAGNESIUM HYDROXIDE
Label structure11 sections
Dosage and administration
• shake well before use • do not exceed the maximum recommended daily dose in a 24 hour period • dose may be taken once a day preferably at bedtime, in divided doses or as directed by a doctor • drink a full glass (8oz) of liquid with each dose age dose Adults and children over 12 years of age Take 30mL (one unit dose) to 60mL (2 unit dose) Children under 12 years of age Ask a doctor
Storage and handling
• each 30 mL (unit dose) contains Magnesium 1000 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
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient per 30mL (1 Unit Dose)
Magnesium hydroxide 2,400 mg
Purpose
Saline laxative
Uses
SPL UNCLASSIFIED SECTION
• relieves occasional constipation (irregularity)
• usually produces bowel movement in ½ hour to 6 hours
Warnings
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have • Kidney disease • a magnesium-restricted diet • Stomach pain • a sudden change in bowel habits that lasts over 14 days
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
• Taking a prescription drug. • This product may interact with certain prescription drugs
Stop use and ask a doctor if
• you have rectal bleeding or no bowel movement after using this product. These may be signs of a serious condition
• you need to use a laxative for more than 1 week
OTC - PREGNANCY OR BREAST FEEDING SECTION
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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
SPL UNCLASSIFIED SECTION
• shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime, in divided doses or as directed by a doctor
• drink a full glass (8oz) of liquid with each dose
| age | dose |
| Adults and children over 12 years of age | Take 30mL (one unit dose) to 60mL (2 unit dose) |
| Children under 12 years of age | Ask a doctor |
Other information
• each 30 mL (unit dose) contains Magnesium 1000 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 purified water, and sodium hypochlorite.
NDC Information -
2400 mg/30 mL
Each 30 mL of Milk of Magnesia contains Magnesium hydroxide 2,400mg and is supplied in the following oral dosage forms:
NDC 57237-314-03 unit dose cup 30mL
NDC 57237-314-31 (100x30) unit dose cups 30mL
OTC - QUESTIONS SECTION
Questions or comments?Call 1-844-474-7464
SPL UNCLASSIFIED SECTION
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
FG-37/Iss.: 04/2023
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
2400 mg/30 mL
Lid Label NDC 57237-314-03
2400 mg/30 mL
Case Label NDC 57237-314-31
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 253017 | magnesium hydroxide 1200 MG in 15 mL Oral Suspension | PSN | 3 |
| 253017 | magnesium hydroxide 80 MG/ML Oral Suspension | SCD | 3 |
| 253017 | magnesium hydroxide 1200 MG per 15 ML Oral Suspension | SY | 3 |
| 253017 | milk of magnesia 2400 MG per 30 ML Oral Suspension | SY | 3 |
| 253017 | milk of magnesia 400 MG per 5 ML Oral Suspension | SY | 3 |
| 253017 | milk of magnesia 8 % Oral Suspension | SY | 3 |
| 253017 | milk of magnesia 80 MG/ML Oral Suspension | SY | 3 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-314-03 | Milk of Magnesia | 30 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 30 | 3 | |
| 57237-314-31 | Milk of Magnesia | 100 in 1 BOX, UNIT-DOSE | SUSPENSION | 100 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-314-03 | ML - Milliliter | 57237-314 | 9c03faa5-3973-4102-b659-28e77fae7e09 | 1 | 2023-12-05 |
| 57237-314-31 | ML - Milliliter | 57237-314 | f3fcf2e5-8106-4228-889c-0a3e0e067c60 | 1 | 2023-12-05 |
Products#
Every source-derived product name is available through these pages.
- Milk of Magnesia
- magnesium hydroxide
- WATER
- SODIUM HYPOCHLORITE
- MAGNESIUM CATION
- HYDROXIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57237-314 | 57237-314-03, 57237-314-31 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SODIUM HYPOCHLORITE | DY38VHM5OD | IACT |
| MAGNESIUM HYDROXIDE | NBZ3QY004S | 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 |
|---|---|---|---|---|---|---|
| Milk of Magnesia | MAGNESIUM HYDROXIDE | Rising Pharma Holdings, Inc. | dfede6bd-df37-4f0f-9944-49dc13c967de | 2025-07-01 | Warnings | 57237-314-31 57237-314-03 57237-314 57237031403 57237031431 bd43f44b-9295-4a99-9c18-18bb52b67887 dfede6bd-df37-4f0f-9944-49dc13c967de |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.