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| Product NDC Code | 69618-043 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Docusate sodium |
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| Type | Generic | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | CAPSULE | ||||||
| RxCUI drug identifier | 1115005 | ||||||
| Application Number | part334 | ||||||
| Labeler Name | Reliable 1 Laboratories 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 adults and children 12 years and over take 1 -3 softgels once daily or in divided doses children 2 to under 12 years of age 1 softgel once daily children under 2 years ask a doctor
| adults and children 12 years and over | take 1 -3 softgels once daily or in divided doses | |
| children 2 to under 12 years of age | 1 softgel once daily | |
| children under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and white edible ink
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 relieves occasional constipation (irregularity) generally produces bowel movement in 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 D&C RED NO. 33 ANHYDROUS CITRIC ACID FD&C RED NO. 40 FD&C BLUE NO. 1 DOCUSATE SODIUM DOCUSATE FD&C YELLOW NO. 6 WATER SORBITOL GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL PC1
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.PRINCIPLINE DISPLAY PANEL - Bottle Label 100ct NDC 69618-043-01 Docusate Sodium 100 mg 100 SOFTGELS STOOL SOFTENER LAXATIVE Bottle Label 100ct front Bottle Label 100ct back
PRINCIPLINE DISPLAY PANEL - Bottle Label 1000ct NDC 69618-043-10 Docusate Sodium 100 mg 1000 SOFTGELS STOOL SOFTENER LAXATIVE Bottle Label 1000ct
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
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
*Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Colace®
Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580 www.reliable1labs.com
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 have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.each softgel contains: sodium 5 mg store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
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 ? Call 516-341-066 8:30 am - 4:30 pm ET, Monday - Friday
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 and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be sings of a serious condition. you need to use a stool softener laxative for more than 1 week
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.Warnings Do not use if you are presently taking mineral oil, unless directed to do so 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