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| Product NDC Code | 63739-478 | ||||
|---|---|---|---|---|---|
| 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 | 505G(a)(3) | ||||
| Labeler Name | McKesson Corporation | ||||
| 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 capsule) Docusate Sodium 100mg
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 Adults and children over 12 years of age: take 1-2 capsules, preferably at bedtime Children 6-12 years of age: take 1 capsule at bedtime
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C red #40, gelatin, glycerin, polyethylene glycol, propyleneglycol and sorbitol special. May also contain: D&C yellow #10, FC&C yellow #6 and purified water.
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 the prevention of dry, hard stools for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.
Purpose
Information about the drug product’s indications for use.Purpose Stool Softener
Spl product data elements
Usually a list of ingredients in a drug product.Docusate Sodium Docusate Sodium GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SORBITOL FD&C YELLOW NO. 6 WATER DOCUSATE SODIUM DOCUSATE GELATIN, UNSPECIFIED FD&C RED NO. 40 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.Docusate Sodium Label Image
mckessondsslabel.jpg
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 capsule contains: sodium 5 mg store at controlled room temperature 15° - 30°C (59° - 86°F)
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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Product: 63739-478
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 for longer than 1 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 you fail to have a bowel movement after use If pregnant or breast-feeding, ask a health 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