FDA.reportPublic FDA data

MiraFAST KIDS soft chews UI1615762

Manufacturer
Bayer HealthCare LLC.
Effective date
2026-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-08 02:02:24

Label at a glance#

ProductMiraFAST KIDS soft chews
Active ingredientMAGNESIUM HYDROXIDE
Label structure11 sections

Indications and uses

relieves occasional constipation (irregularity). This product usually produces bowel movement in 1/2 to 6 hours.

Dosage and administration

drink a full glass (8 oz) of liquid with each dose. dose may be taken as a single daily dose, in divided doses, or as directed by a doctor. do not exceed the maximum recommended daily dose in a 24 hour period adults and children 12 years of age and over 2 to 4 chews children 6 to under 12 years of age 1 to 2 chews children 4 to 6 years of age 1 chew children under 4 years of age ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide USP 1200mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity). This product usually produces bowel movement in 1/2 to 6 hours.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet
  • stomach pain, nausea, or vomiting
  • a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass (8 oz) of liquid with each dose.
  • dose may be taken as a single daily dose, in divided doses, or as directed by a doctor.
  • do not exceed the maximum recommended daily dose in a 24 hour period
adults and children 12 years of age and over2 to 4 chews
children 6 to under 12 years of age1 to 2 chews
children 4 to 6 years of age1 chew
children under 4 years of ageask a doctor

Other information

OTHER SAFETY INFORMATION

  • each chew contains: magnesium 500mg, sodium 1mg
  • store between 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat and humidity.
  • Do not use if pouch is torn or open

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn syrup, FD&C red no. 40 aluminum lake, flavors, glycerin, hydrogenated coconut oil, soy lecithin, sucrose, water.

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments? 1-800-647-2529

MiraFAST Soft Chews

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041100607041GTIN-13: 0041100607041
EAN-13: 0041100607041
GTIN-12: 041100607041
UPC-A: 041100607041
GTIN storage (14 digits): 00041100607041		MiraFAST Kids_Soft_Chews.jpg

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-829611523-8296-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
CORN SYRUP9G5L16BK6NIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
WATER059QF0KO0RIACT
SUCROSEC151H8M554IACT

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
MiraFAST KIDS soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.58636827-239d-cc63-e063-6294a90a61802026-08-06WarningsExact identifier
ndc (package): 11523-8296-1
ndc (product): 11523-8296
ndc11 (package): 11523829601
spl id: 58636827-239e-cc63-e063-6294a90a6180
spl set id: 58636827-239d-cc63-e063-6294a90a6180

Reported adverse events (FAERS/openFDA)#

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