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Product NDC Code | 49483-079 | ||||||
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Drug Name | Sennosides |
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Type | Generic | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | TABLET, SUGAR COATED | ||||||
RxCUI drug identifier | 200162 | ||||||
Application Number | part334 | ||||||
Labeler Name | TIME CAP LABORATORIES, INC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Each Tablet contains: Sennosides 15 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. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable. Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day Children 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day Children under 2 years - Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS:acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, FD&C Red#40, FD&C Yellow#6, iron oxide, iron oxide black, iron oxide yellow, Kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol(PEG 400), povidone, Shellac, 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.Uses: Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours
Purpose
Information about the drug product’s indications for use.stool softner, laxative
Spl product data elements
Usually a list of ingredients in a drug product.SENNOSIDES SENNOSIDES TALC ACACIA SENNOSIDES A AND B SENNOSIDES A AND B POVIDONE SHELLAC TITANIUM DIOXIDE FERRIC OXIDE YELLOW CALCIUM SULFATE ANHYDROUS CALCIUM CATION CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSCARMELLOSE FERROSOFERRIC OXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID KAOLIN MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED RAW SUGAR TCL079
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.190R LABEL
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 the reach of children. Incase 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