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Product NDC Code | 70000-0445 | ||||
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Drug Name | Senna plus |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | CAPSULE, GELATIN COATED | ||||
RxCUI drug identifier | 1791612 | ||||
Application Number | M007 | ||||
Labeler Name | Cardinal Health | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Purpose (in each softgel) Docusate sodium 50 mg..............................Stool softener Sennosides 8.6 mg................................................Laxative
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 dose Maximum Dosage adults and children 12 years of age or older 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
Age | Starting dose | Maximum Dosage |
adults and children 12 years of age or older | 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 FD&C yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone (PVP K-30), propylene glycol, purified water, sorbitol, 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.Active ingredients Purpose (in each softgel) Docusate sodium 50 mg..............................Stool softener Sennosides 8.6 mg................................................Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Senna Plus Docusate Sodium, 50 mg Sennosides, 8.6 mg FD&C YELLOW NO. 6 GELATIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER TITANIUM DIOXIDE SORBITOL SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE Opaque Softgel S62
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 Softgels Bottle Carton NDC 70000-0445-1 Senna Plus Docusate Sodium, 50 mg | Sennosides, 8.6 mg Stool Softener | Laxative COMPARE TO SENOKOT-S¬ active ingredients* Dual Action Standardized Senna Concentrate 60 SOFTGELS Actual Size 100% Money Back Guarantee 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
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 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 (1-800-222-1222) right away.
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 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 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 (1-800-222-1222) right away.
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 (1-800-222-1222) 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. 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 (1-800-222-1222) right away.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 (1-800-222-1222) right away.
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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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 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 (1-800-222-1222) 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