Stool Softener 100 mg/1
Docusate Sodium · CAPSULE, LIQUID FILLED · RMT HEALTH LLC
Stool Softener is a capsule, liquid filled containing docusate sodium at 100 mg/1, taken oral. Manufactured by RMT HEALTH LLC.
Key Facts
- Brand Name
- Stool Softener
- Generic Name
- Docusate Sodium
- NDC Code (Product)
85111-401- Manufacturer
- RMT HEALTH LLC
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- M007
- Marketing Start
- 09/01/2025
Recall History
Geritrex, LLC
cGMP Deviations: Products may have microbial contamination.
Pharmatech LLC
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
The Harvard Drug Group
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Allegiant Health
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
The Harvard Drug Group
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
The Harvard Drug Group
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
National Vitamin Co Inc
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Geritrex, LLC
cGMP Deviations: Products may have microbial contamination.
Akron Pharma, Inc.
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses for relief of occasional constipation and irregularity this product generally produces bowel movement in 12 to 72 hours
Dosage & Administration
Directions take with a glass of water adults and children 12 years and over take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses. children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor
Warnings
Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using a laxative. These could be a sign of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) right away.
Frequently Asked Questions
What is Stool Softener used for?
Stool Softener contains Docusate Sodium. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.
Is Stool Softener a controlled substance?
Stool Softener is not classified as a controlled substance by the DEA.
What is the generic name for Stool Softener?
The generic name for Stool Softener is Docusate Sodium. There are 12 other brand versions of Docusate Sodium.
What is the NDC code for Stool Softener 100 mg/1?
The NDC (National Drug Code) for Stool Softener 100 mg/1 is 85111-401, listed by RMT HEALTH LLC.
Other Docusate Brands
See all →- Stool Softener Laxative100 mg/172476-041
- Topcare Stool Softener100 mg/176162-761
- Quality Choice Stool Softener100 mg/183324-197
- Docusate Sodium100 mg/10mL0904-7279
- Stool Softener Laxative250 mg/10904-7281
- ENEMEEZ283 mg/5mL17433-9876
- Stool Softener Laxative100 mg/121130-853
- Docusate Sodium100 mg/10mL0121-1870
- Pedia-Lax50 mg/15mL0132-0113
- H E B Stool Softener laxative250 mg/137808-293
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)