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| Product NDC Code | 35916-0454 | ||||
|---|---|---|---|---|---|
| Drug Name | Docusate sodium and sennosides |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, GELATIN COATED | ||||
| RxCUI drug identifier | 1791612 | ||||
| Application Number | M007 | ||||
| Labeler Name | Softgel Healthcare Pvt Ltd | ||||
| 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 50 mg Sennosides 8.6 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 preferably at bedtime or as directed by a doctor. Age Starting Dosage Maximum Dosage adults and children 12 years of age and older 2 softgels once a day 4 softgels twice a day children 6 to 12 years of age 1 softgel once a day 2 softgels twice a day children under 6 years of age ask a doctor ask a doctor
| adults and children 12 years of age and older | 2 softgels once a day | 4 softgels twice a day |
| children 6 to 12 years of age | 1 softgel once a day | 2 softgels twice a day |
| children under 6 years of age | ask a doctor | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Propylene glycol, Povidone, Colloidal Silicon Dioxide, Yellow wax, Polyethylene glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD&C Red No.40, Titanium dioxide 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 relieves occasional constipation (irregularity) generally causes bowel movement in 6-12 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 and Sennosides Docusate Sodium and Sennosides POVIDONE K30 YELLOW WAX GLYCERIN PROPYLENE GLYCOL FD&C RED NO. 40 WATER GELATIN SORBITOL TITANIUM DIOXIDE SILICON DIOXIDE POLYETHYLENE GLYCOL 400 DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES 903 opaque
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.Bottle Label
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 movements that continues 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, seek professional assistance 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.Other information each softgel contains: Sodium 3 mg store at 25°C (77°F); excursions permitted between 15°- 30°C (59°- 86°F)
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 a bowel movement after use of a laxative. These may be signs of a serious condition.
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 now taking mineral oil, unless directed by a doctor laxative products 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