Stool Softener 100 mg/1
Stool Softener · CAPSULE, LIQUID FILLED · Good Sense
Stool Softener is a capsule, liquid filled containing stool softener at 100 mg/1, taken oral. Manufactured by Good Sense.
Key Facts
- Brand Name
- Stool Softener
- Generic Name
- Stool Softener
- NDC Code (Product)
50804-424- Manufacturer
- Good Sense
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- M007
- Marketing Start
- 06/18/2024
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 Stool Softener. 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 Stool Softener. There are 1 other brand versions of Stool Softener.
What is the NDC code for Stool Softener 100 mg/1?
The NDC (National Drug Code) for Stool Softener 100 mg/1 is 50804-424, listed by Good Sense.