Docusate Sodium 250 mg/1
Docusate Sodium · CAPSULE, LIQUID FILLED · Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Docusate sodium is a stool softener that helps relieve constipation by making bowel movements easier and less painful. It works by increasing the amount of water in stool to soften it, and is available over-the-counter as a capsule or liquid-filled form.
Key Facts
- Brand Name
- Docusate Sodium
- Generic Name
- Docusate Sodium
- NDC Code (Product)
53345-035- Manufacturer
- Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
- Strength
- 250 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- M007
- Marketing Start
- 02/10/2016
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 is a stool softener that helps relieve constipation by making bowel movements easier and less painful. It works by increasing the amount of water in stool to soften it, and is available over-the-counter as a capsule or liquid-filled form.
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. There are 10 other brand versions of Docusate Sodium.
What is the NDC code for Docusate Sodium 250 mg/1?
The NDC (National Drug Code) for Docusate Sodium 250 mg/1 is 53345-035, listed by Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.
Other Docusate Sodium Dosages
Other Docusate Brands
See all →- Stool Softener Laxative100 mg/172476-041
- Topcare Stool Softener100 mg/176162-761
- Quality Choice Stool Softener100 mg/183324-197
- Stool Softener Laxative250 mg/10904-7281
- ENEMEEZ283 mg/5mL17433-9876
- Stool Softener Laxative100 mg/121130-853
- Pedia-Lax50 mg/15mL0132-0113
- H E B Stool Softener laxative250 mg/137808-293
- Stool Softener Extra Strength250 mg/141250-859
- DOCUSATE SODIUM50 mg/5mL48433-220
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)