Docusate Sodium 100 mg/1
Docusate Sodium 100mg · CAPSULE · Pharbest Pharmaceuticals, Inc.
Docusate Sodium is a capsule containing docusate sodium 100mg at 100 mg/1, taken oral. Manufactured by Pharbest Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Docusate Sodium
- Generic Name
- Docusate Sodium 100mg
- NDC Code (Product)
16103-399- Manufacturer
- Pharbest Pharmaceuticals, Inc.
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- M
- Marketing Start
- 03/01/2016
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
Aidapak Services, LLC
Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W003030, EXP: 6/12/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: AD21790_64, EXP: 5/1/2014; TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), NDC 00591533501, Pedigree: AD7
Pharmatech LLC
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Sato Pharmaceutical Inc.
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Rx Pak Division of McKesson Corporation
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
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
Aidapak Services, LLC
Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD60211_1, EXP: 5/21/2014; MEXILETINE HCL, Capsule, 150 mg, NDC 00093873901, Pedigree: AD62865_7, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD65457_10, EXP: 5/24/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Dosage & Administration
Directions Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-3 softgels daily 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 you have 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 fail to have bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a stool softener laxative for more than 1 week 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. (1-800-222-1222)
Frequently Asked Questions
What is Docusate Sodium used for?
Docusate Sodium contains Docusate Sodium 100mg. It is a capsule taken oral. Consult your doctor for specific uses.
Is Docusate Sodium a controlled substance?
Docusate Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Docusate Sodium?
The generic name for Docusate Sodium is Docusate Sodium 100mg. There are 2 other brand versions of Docusate Sodium 100mg.
What is the NDC code for Docusate Sodium 100 mg/1?
The NDC (National Drug Code) for Docusate Sodium 100 mg/1 is 16103-399, listed by Pharbest Pharmaceuticals, Inc..