FDA.reportPublic FDA data

BET-R-PREP Magnesium Citrate Oral Solution

Manufacturer
Satius Pharmaceuticals, LLC
Effective date
2018-01-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:04:06

Label at a glance#

ProductBET-R-PREP Magnesium Citrate Oral
Active ingredientMAGNESIUM CITRATE
Label structure8 sections

Indications and uses

Relieves occasional constipation (irregularity) Generally produces bowel movement in ½ to 6 hours

Dosage and administration

Adults and children 12 years of age and older: ½ to 1 bottle (10 fl. oz). Drink a full 8 oz. glass of liquid with each dose. The dose may be taken as a single daily dose or in divided doses. Children 6 to 11 years of age: 1/3 to ½ bottle with a full 8 oz. glass of liquid Children under 6 years of age: Consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesium citrate 1.745g per fl. Oz

Purpose

OTC - PURPOSE SECTION

Saline Laxative

Uses

INDICATIONS & USAGE SECTION

  • Relieves occasional constipation (irregularity)
  • Generally produces bowel movement in ½ to 6 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

laxative products for longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Kidney disease
  • A sodium restricted diet
  • Noticed a sudden change in bowel habits that lasts more than 1 week
  • A magnesium restricted diet
  • Stomach pain, nausea or vomiting

Ask a doctor or pharmacist before use if you are 

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug.

When using this product,

OTC - WHEN USING SECTION

do not exceed the maximum recommended daily dosage in a 24 hour period.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or no bowel movement after use. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:
½ to 1 bottle (10 fl. oz). Drink a full 8 oz. glass of liquid with each dose. The dose may be taken as a single daily dose or in divided doses.
Children 6 to 11 years of age:
1/3 to ½ bottle with a full 8 oz. glass of liquid
Children under 6 years of age: Consult a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • Each fluid ounce contains: magnesium 282 mg, sodium 37 mg
  • Store between 46-86 degrees F (8-30 degrees C). Do not refrigerate.
  • Protect from excessive heat and freezing
  • Discard unused product within 24 hours of opening bottle

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, citric acid, sodium bicarbonate, saccharin sodium, natural and artificial flavors, zinc gluconate, potassium citrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday – Friday 9AM-5PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NewLabelNewLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71890-32071890-320-29

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
POTASSIUM CITRATEEE90ONI6FFIACT
MAGNESIUM CITRATERHO26O1T9VACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
071dd31b-6aee-4981-e063-6294a90ada5c50314e6b-c2bf-4e6e-94e8-220044c959d92023-10-07WarningsExact identifier
spl set id: 50314e6b-c2bf-4e6e-94e8-220044c959d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.