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Product NDC Code | 11822-3065 | ||||||||
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Drug Name | Senna-s |
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Type | Brand | ||||||||
Active Ingredients |
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Route | ORAL | ||||||||
Dosage Form | TABLET, COATED | ||||||||
RxCUI drug identifier | 998740 | ||||||||
Application Number | part334 | ||||||||
Labeler Name | RITE AID | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each tablet) Docustate 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 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 (do not exceed maximum dosage) or decrease dose until you are comfortable age starting dosage maximum dosage adults and children 12 years and over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years ½ tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor
adults and children 12 years and over | 2 tablets once a day | 4 tablets twice a day |
children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
children 2 to under 6 years | ½ tablet once a day | 1 tablet twice a day |
children under 2 years | ask a doctor | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yelow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, 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.Purposes Stool softener Stimulant laxative
Spl product data elements
Usually a list of ingredients in a drug product.SENNA-S DOCUSATE SODIUM AND SENNOSIDES HYPROMELLOSES MICROCRYSTALLINE CELLULOSE STEARIC ACID DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C YELLOW NO. 6 SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 CARNAUBA WAX SILICON DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM BENZOATE TITANIUM DIOXIDE MAGNESIUM STEARATE TCL081
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.192R-RA-laxative-30s-label 192R-RA-laxative-30s-ifc 192R-Rite Aid-Laxative Stool Softner Tablets-bottle label-60s 192R-Rite Aid-Laxative Stool Softner Tablets-carton label-60s 192R-Rite Aid-Laxative Stool Softner Tablets-bottle label-120s 192R-Rite Aid-Laxative Stool Softner Tablets-carton label-120s
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
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 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
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM) store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
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 1-877-290-4008
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 to have a bowel movement after use of a laxative. These could be signs of a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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
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