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| Product NDC Code | 60687-129 | ||||
|---|---|---|---|---|---|
| Drug Name | Docusate sodium |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1115005 | ||||
| Application Number | part334 | ||||
| Labeler Name | American Health Packaging | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each softgel) Docusate Sodium 100 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years of age and over take 1 to 3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl. Distributed by: American Health Packaging 2550 John Glenn Avenue, Suite A Columbus, OH 43217 712901 0412901/0216PS
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for relief of occasional constipation (irregularity) generally produces a bowel movement within 12 to 72 hours
Purpose
Information about the drug product’s indications for use.Purpose Stool softener laxative
Spl product data elements
Usually a list of ingredients in a drug product.Docusate Sodium Docusate Sodium FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 WATER SORBITOL DOCUSATE SODIUM DOCUSATE Reddish SCU1
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel – Carton – 100 mg NDC 60687- 129 -01 DOCUSATE SODIUM, USP Stool Softener Laxative 100 mg 100 Softgels (10 x 10) The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl. Packaged and Distributed by: American Health Packaging Columbus, OH 43217 712901 0412901/0119 100 mg Docusate Sodium Softgels Carton Label
Principal Display Panel - Blister – 100 mg DOCUSATE SODIUM, USP Stool Softener Laxative Softgel 100 mg 100 mg Docusate Sodium Softgel Blister
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information Each softgel contains: sodium 7 mg VERY LOW SODIUM Store at room temperature between 15° to 30°C (59° to 86°F) FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use if you are currently taking mineral oil, unless directed by a doctor when abdominal pain, nausea or vomiting are present unless directed by a doctor for longer than one week unless directed by a doctor Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks. Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition. If pregnant or breast-feeding, ask a health care professional before use.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API