Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 70000-0442 | ||||
|---|---|---|---|---|---|
| Drug Name | Stool softener and stimulant laxative |
||||
| Type | Brand | ||||
| Active Ingredients |
|
||||
| Route | ORAL | ||||
| Dosage Form | CAPSULE, GELATIN COATED | ||||
| RxCUI drug identifier | 1791612 | ||||
| Application Number | M007 | ||||
| Labeler Name | Cardinal Health | ||||
| Packages |
|
||||
| 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 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 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 of age or over take 2-4 softgels daily children 6 to under 12 years of age take 1-2 softgels daily children 2 to under 6 years of age take upto 1 softgel daily children under 2 ask a doctor
| adults and children 12 years of age or over | take 2-4 softgels daily |
| children 6 to under 12 years of age | take 1-2 softgels daily |
| children 2 to under 6 years of age | take upto 1 softgel daily |
| children under 2 | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aerosil, beeswax, FD&C Red No.33, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, 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 6-12 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 AND STIMULANT LAXATIVE DOCUSATE SODIUM AND SENNOSIDES POVIDONE K30 WATER CARBOXYMETHYLCELLULOSE SODIUM SORBITOL LECITHIN, SOYBEAN TITANIUM DIOXIDE DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES SILICON DIOXIDE YELLOW WAX D&C RED NO. 33 FD&C RED NO. 40 GELATIN GLYCERIN LIGHT MINERAL OIL OPAQUE SOFTGEL 584
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 - 60 Capsule Bottle Carton Leader™ NDC 70000-0442-1 Stool Softener + Stimulant Laxative Docusate Sodium, 50 mg Sennosides, 8.6 mg COMPARE TO COLACE® 2-IN-1 active ingredients* 100% Money Back Guarantee 60 SOFTGELS Actual Size image description
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
*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace® 2-IN-1. © 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Made in India All LEADER™ Brand Products Have A Return to place of purchase if not satisfied. 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use laxative products for longer than 1 week unless told to do so by a doctor if you are presently taking mineral oil, unless told to do so by a doctor
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 (1800-222-1222) 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 or Comments? 1-888-333-9792
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 indicate a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each softgel contains: calcium 2 mg and sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Keep tightly closed
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 told to do so by a doctor if you are presently taking mineral oil, unless told to do so 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 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 (1800-222-1222) 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