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Drug Facts
Mirasoft Stool Softener Capsule, Liquid Filled
FDA Label NDC 11523-8259
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Mirasoft Stool Softener (NDC 11523-8259). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each softgel), purpose, use, warnings, ask a doctor before use if you have, drug interactions, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Docusate sodium 100 mg
Purpose
Stool softener laxative
Use
- for relief of occasional constipation (irregularity)
- this product generally produces a bowel movement in 12 to 72 hours
Warnings
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
- stomach pain, nausea, or vomiting
- a sudden change in bowel habits that lasts over 14 days
Drug Interactions
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
- 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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- 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
- each softgel contains: sodium 5 mg
- store at room temperature. Avoid excessive heat 40°C (104°F).
Inactive Ingredients
gelatin, glycerin, pharmaceutical ink, polyethylene glycol, purified water, sorbitol sorbitan solution. Softgels are imprinted with edible pharmaceutical ink.
Questions Or Comments?
1-800-647-2529 (Mon – Fri 9AM – 5PM EST)
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