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| Product NDC Code | 68210-0350 | ||||
|---|---|---|---|---|---|
| Drug Name | Docusate sodium |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| Application Number | M007 | ||||
| Labeler Name | Spirit Pharmaceuticals LLC | ||||
| 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 gelcaps) 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 adult and children 12 years and over: take 1-3 gelcaps, preferably at bedtime children 2 to under 12 years of age: take 1 gelcap at bedtime 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 #33, FD&C Red#40, FD&C Yellow#6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide.
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 the dry, hard stools for relief of occassional 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 Softner
Spl product data elements
Usually a list of ingredients in a drug product.DOCUSATE SODIUM DOCUSATE SODIUM POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SHELLAC WATER GELATIN GLYCERIN SORBITOL D&C RED NO. 33 FD&C RED NO. 40 FD&C YELLOW NO. 6 TITANIUM DIOXIDE DOCUSATE SODIUM DOCUSATE 413
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.PRICNIPAL DISPLAY PANEL Compare to the active ingredient in Colace ® Gel Caps * STOOL SOFTENER DOCUSATE SODIUM 100 mg Gentle Effective Stimulant-Free Relief 100 GELCAPS Docusate 100 mg 100ct
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.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks
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 accidental overdose, get medical help or contact a Poison Control Center 1-800-222-1222 immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temperature 15-30°C (59-86°F) do not use if safety seal under cap is torn or missing
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-888-333-9792
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use abd ask a doctor if you have rectal bleeding fail to have a bowel movement occur after use.
Stop use and ask a doctor if you have rectal bleeding fail to have bowel movement occur after use.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center 1(800)222-1222 immediately.
If pregnant or breast feeding Ask a health professional before use
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.Do not use if you are currently taking mineral oil, unless directed to so by a doctor. When abdominal pain, nausea, or vomiting are present for longer than 1 week unless directed by a doctor
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