FDA.reportPublic FDA data

MiraFAST soft chews UI1615762

Manufacturer
Bayer HealthCare LLC.
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-25 01:02:27

Label at a glance#

ProductMiraFAST 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.

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-130041100604583GTIN-13: 0041100604583
EAN-13: 0041100604583
GTIN-12: 041100604583
UPC-A: 041100604583
GTIN storage (14 digits): 00041100604583		Mirafast Soft Chews 30ct Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

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
11523-015911523-0159-1, 11523-0159-2, 11523-0159-3, 11523-0159-4

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-08-05daily-update2026-08-08 02:01:24
12025-01-30full-release2026-06-01 00:55:40

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 soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-21WarningsExact identifier
ndc (package): 11523-0159-1
ndc (package): 11523-0159-4
ndc (package): 11523-0159-2
ndc (package): 11523-0159-3
ndc (product): 11523-0159
ndc11 (package): 11523015901
ndc11 (package): 11523015903
ndc11 (package): 11523015904
ndc11 (package): 11523015902
spl id: 59911b66-9545-f86c-e063-6394a90a3eab
spl set id: 2cee67dd-b71f-32b8-e063-6394a90ae864

Reported adverse events (FAERS/openFDA)#

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