MiraSOFT Stool Softener UI1615969

Manufacturer: Bayer HealthCare LLC.
Effective date: 2026-10-07
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: daily-update
Hydrated at: 2026-10-10 01:02:06

Label at a glance#

ProductMiraSOFT Stool Softener

Active ingredientDOCUSATE SODIUM

Label structure10 sections

Dosage and administration

take softgels with a full glass (8 oz) of water adults and children 12 years and older take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. children 6 to under 12 years take 1 softgel daily or as directed by a doctor children under 6 years of age ask a doctor

Storage and handling

each softgel contains: sodium 5 mg store at room temperature. Avoid excessive heat 40°C (104°F).

Contacts and useful links#

PhoneLabel contact1-800-647-2529

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Use

INDICATIONS & USAGE SECTION

for relief of occasional constipation (irregularity)
this product generally produces a bowel movement in 12 to 72 hours

Warnings

WARNINGS 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

stomach pain, nausea, or vomiting
a sudden change in bowel habits that lasts over 14 days

DRUG INTERACTIONS SECTION

Drug Interaction Precaution: Do not take this product if you are presently taking mineral oil, unless directed by doctor.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

take softgels with a full glass (8 oz) of water

adults and children 12 years and older	take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years	take 1 softgel daily or as directed by a doctor
children under 6 years of age	ask a doctor

Other information

STORAGE AND HANDLING SECTION

each softgel contains: sodium 5 mg
store at room temperature. Avoid excessive heat 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, pharmaceutical ink, polyethylene glycol, purified water, sorbitol sorbitan solution. Softgels are imprinted with edible pharmaceutical ink.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-647-2529 (Mon – Fri 9AM – 5PM EST)

PRINCIPAL DISPLAY PANEL - 30 Capsule Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP.

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0041100607911	GTIN-13: 0041100607911 EAN-13: 0041100607911 GTIN-12: 041100607911 UPC-A: 041100607911 GTIN storage (14 digits): 00041100607911	MiraSOFT Stool Softener.jpg

Products#

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

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

MiraSOFT Stool Softener
docusate sodium
DOCUSATE
WATER
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
SORBITOL
SORBITAN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-8259	11523-8259-3, 11523-8259-6

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
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
WATER	059QF0KO0R	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SORBITOL	506T60A25R	IACT
SORBITAN	6O92ICV9RU	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2026-08-05	daily-update	2026-08-08 02:00:59

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5851f15f-8ade-559f-e063-6394a90a7b7d			5851f15f-8add-559f-e063-6394a90a7b7d	2026-08-05	Warnings	Exact identifier spl set id: 5851f15f-8add-559f-e063-6394a90a7b7d

Reported adverse events (FAERS/openFDA)#

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