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| Product NDC Code | 68016-623 | ||||
|---|---|---|---|---|---|
| Drug Name | Stool softener with laxative |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, FILM COATED | ||||
| RxCUI drug identifier | 998740 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | PHARMACY VALUE ALLIANCE, 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 tablet) 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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses adults and children 12 years and over take 2-4 tablets daily children under 12 years of age ask a doctor
| adults and children 12 years and over | take 2-4 tablets daily |
| children under 12 years of age | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cellulose, croscarmellose sodium, dicalcium phosphate, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, PEG, silica, talc, 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 relieves occasional constipation (irregularity) this product generally produces bowel movement in 6 to 12 hours
Purpose
Information about the drug product’s indications for use.Purpose Stool softener Stimulant laxative
Spl product data elements
Usually a list of ingredients in a drug product.Stool Softener with Laxative Docusate Sodium and Sennosides TALC POLYETHYLENE GLYCOL, UNSPECIFIED HYPROMELLOSES FD&C BLUE NO. 2 TITANIUM DIOXIDE SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE FD&C RED NO. 40 SILICON DIOXIDE PSD21
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.Package Label 304
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information each tablet contains: calcium 20 mg, sodium 3 mg store at controlled room temperature Tamper Evident: Do not use if imprinted seal under cap is missing or broken. product of India
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 laxative products for longer than 1 week unless directed by a doctor if you are presently taking mineral oil, unless directed by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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