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Product NDC Code | 70000-0077 | ||||
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Drug Name | Maximum strength laxative |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET | ||||
RxCUI drug identifier | 251292 | ||||
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 INGREDIENT Each Tablet contains: SENNOSIDES,USP 25 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: Swallow tablet(s) with a glass of water Swallow tablet(s) whole do not crush, break, or chew Adults and children 12years of age and older Take 2 tablets once or twice daily Children 6 to under 12 years of age Take 1 tablet once or twice daily children under 6 years of age ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS INACTIVE INGREDIENTS: acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, 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.INDICATIONS & USAGE Uses: Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours
Purpose
Information about the drug product’s indications for use.PURPOSE: Stimulant Laxative
Spl product data elements
Usually a list of ingredients in a drug product.MAXIMUM STRENGTH LAXATIVE SENNOSIDES CROSCARMELLOSE FERROUS OXIDE FD&C BLUE NO. 1 FERRIC OXIDE YELLOW MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE DIBASIC CALCIUM PHOSPHATE DIHYDRATE KAOLIN RAW SUGAR ACACIA SENNOSIDES SENNOSIDES FERROSOFERRIC OXIDE STEARIC ACID MALTODEXTRIN CARNAUBA WAX STARCH, CORN CALCIUM SULFATE ANHYDROUS CALCIUM CATION SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE SHELLAC TALC TITANIUM DIOXIDE TCL083
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.24 COUNT
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.
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 this product If you are presently taking mineral oil, unless directed by a doctor Laxative products for longer than 1 week unless directed by a doctor
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