OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Magnesium citrate 1.745 g per fl oz
OTC - PURPOSE SECTION
Purpose
Saline laxative
Magnesium Citrate
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2022-02-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:09:16
Label at a glance#
ProductMagnesium Citrate
Active ingredientMAGNESIUM CITRATE
Label structure7 sections
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Use for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours
WARNINGS SECTION
Warnings
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
•kidney disease
•a magnesium or potassium-restricted diet
•abdominal pain, nausea, or vomiting
•noticed a sudden change in bowel habits that persists over a period of 2 weeks
•already used a laxative for a period longer than 1 week
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking any other drug. take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
OTC - STOP USE SECTION
Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.
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 overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions •drink a full glass (8 ounces) of liquid with each dose
• may be taken as a single daily dose or in divided doses
adults and children 12 years of age and over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hours
children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 25 hours
children 2 to 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours
children under 2 years of age- ask a doctor
discard unused product within 24 hours of opening bottle
OTHER SAFETY INFORMATION
Other information
•magnesium content 290 mg per 1 fl oz (30 mL)
•potassium content 80 mg per 1 fl oz (30 mL)
•store at temperaturs between 46⁰ and 86⁰ F (8⁰ and 30⁰ C)
INACTIVE INGREDIENT SECTION
Inactive ingredients cherry flavor, citric acid, FD+C red # 40, potassium bicarbonate, sodium saccharin, water purified
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4128-1 | 2022-02-07 | C162847 | 48780-1 | d6a99b39-6c48-a426-e053-dadaa90af4c2 | Sunmark Magnesium Citrate |
| 68071-4128-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6c48-a426-e053-dadaa90af4c2 | Sunmark Magnesium Citrate |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-504-49 | ML - Milliliter | 49348-504 | f9558363-c1b6-4179-a510-c1a265d0e75b | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Magnesium Citrate
- CITRIC ACID MONOHYDRATE
- FD&C RED NO. 40
- POTASSIUM BICARBONATE
- SACCHARIN SODIUM
- WATER
- MAGNESIUM CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-4128 | 68071-4128-1 |
| 49348-504 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| POTASSIUM BICARBONATE | HM5Z15LEBN | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| WATER | 059QF0KO0R | IACT |
| MAGNESIUM CITRATE | RHO26O1T9V | 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 |
|---|---|---|---|---|---|---|
| 2ad52d81-b0a0-2483-e063-6294a90a4c73 | 5c664215-758d-a7a8-e053-2a91aa0a570e | 2025-01-03 | Warnings | 5c664215-758d-a7a8-e053-2a91aa0a570e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.