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| Product NDC Code | 55154-3369 | ||||
|---|---|---|---|---|---|
| Drug Name | Docusate sodium - stool softener laxative |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1115005 | ||||
| Application Number | M007 | ||||
| Labeler Name | Cardinal Health 107, 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 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 softgel with a full glass (8 oz) of water adults and children 12 years of age and older take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. children 6 to under 12 years of age take 1 softgel daily or as directed by a doctor children under 6 years of age ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution
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) • This 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 - Stool Softener Laxative Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL LIGHT MINERAL OIL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN 777
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 Docusate Sodium 100 mg 10 Softgels Bag Label
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
Distributed by: MAJOR ® PHARMACEUTICALS Livonia, MI 48152 Distributed By: Cardinal Health Dublin, OH 43017 L57466800124 Product of UAE Packaged and Quality Assured in the USA TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING READ FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
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.This unit dose package is not child resistant and is Intended for Institutional Use Only. Keep out of reach of children Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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? (800)616-2471
Storage and handling
Information about safe storage and handling of the drug product.Other information • each softgel contains: sodium 10 mg (very low sodium) • store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).
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 Ask a doctor before use if you have • abdominal pain, nausea, or vomiting • a sudden change in bowel habits that lasts over 14 days Ask a doctor or pharmacist before use if you are presently taking mineral oil Stop use and ask a doctor if • you have rectal bleeding or no bowel movement after using this product. These can be signs of a serious condition • you need to use a laxative for more than 1 week If pregnant or breast-feeding , ask a health care professional before use. This unit dose package is not child resistant and is Intended for Institutional Use Only. Keep out of reach of children Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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