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| Product NDC Code | 70000-0686 | ||||
|---|---|---|---|---|---|
| Drug Name | Leader regular strength senna laxative softgel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 476827 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Cardinal Health 110, LLC. DBA Leader | ||||
| 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) 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 over 2 softgels once a day 4 softgels twice a day children 6 to under 12 years 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 over | 2 softgels once a day | 4 softgels twice a day |
| children 6 to under 12 years | 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 black iron oxide, fumaric acid, gelatin, glycerin, lecithin liquid, methyl paraben, purified water, red iron oxide, sorbitol 70% solution, soybean oil, yellow bees wax
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 a bowel movement in 6-12 hours
Purpose
Information about the drug product’s indications for use.Purpose Laxative
Spl product data elements
Usually a list of ingredients in a drug product.LEADER Regular Strength Senna Laxative SOFTGEL Sennosides SENNOSIDES SENNOSIDES FERROSOFERRIC OXIDE FUMARIC ACID GELATIN, UNSPECIFIED GLYCERIN SOYBEAN LECITHIN METHYLPARABEN WATER FERRIC OXIDE RED SORBITOL SOLUTION SOYBEAN OIL YELLOW WAX 901
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 Softgel
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
Standardized Senna Concentrate Natural Vegetable Laxative Ingredient COMPARE TO SENOKOT ® REGULAR STRENGTH active ingredient* All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. Cardinal Health ™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 Product of India TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION Overnight, gentle laxative *This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark Senokot®. ©2024 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.
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 or comments? Call 1-800-200-6313
Storage and handling
Information about safe storage and handling of the drug product.Other information • each softgel contains: calcium 4 mg • store at room temperature 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 • 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