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| Product NDC Code | 36800-861 | ||||
|---|---|---|---|---|---|
| Drug Name | Laxative docusate sodium with senna |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, COATED | ||||
| RxCUI drug identifier | 998740 | ||||
| Application Number | M007 | ||||
| Labeler Name | TOPCO ASSOCIATES 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 ingredients (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 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 years ask a doctor
| adults and children 12 years and over | take 2-4 tablets daily |
| children 6 to under 12 years of age | take 1-2 tablets daily |
| children 2 to under 6 years of age | take up to 1 tablet daily |
| children under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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) • generally produces bowel movement in 6 to 12 hours
Purpose
Information about the drug product’s indications for use.Purposes Stool softener Stimulant laxative
Spl product data elements
Usually a list of ingredients in a drug product.Laxative Docusate Sodium with Senna Docusate Sodium and Sennosides DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES SILICON DIOXIDE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C BLUE NO. 2 ALUMINUM LAKE FD&C RED NO. 40 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE S154
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.Packaging Laxative
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
+TopCare® health COMPARE TO COLACE ® 2-IN-1 ACTIVE INGREDIENTS* Stool Softener + Stimulant Laxative For Relief Of Occasional Constipation: • Effective • Reliable • Comfortable DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO STVA1120 [email protected] www.topcarebrand.com *This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace ® 2-IN-1. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING KEEP OUTER CARTON FOR COMPLETE 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.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-423-0139
Storage and handling
Information about safe storage and handling of the drug product.Other information • each tablet contains: calcium 20 mg, sodium 3 mg (low sodium) • store between 20-25°C (68-77°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 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 Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that continues over a period of 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 may indicate 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