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| Product NDC Code | 37808-712 | ||||
|---|---|---|---|---|---|
| Drug Name | Sennosides |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 2169295 | ||||
| Application Number | M007 | ||||
| Labeler Name | H E B | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each softgel) Sennosides 17.2 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. adults and children 12 years and over ■ 1 capsule once a day. Maximum 2 capsules twice a day. children 6 to under 12 years ■ maximum 1 capsule twice a day children under 6 years ■ ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C blue no.1, FD&C blue no.2, FD&C red no. 40, FD&C yellow no.6, fumaric acid, gelatin, glycerol, lecithin, liquid sorbitol, methyl hydroxy benzoate, purified water, refined soya oil, titanium dioxide, 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 within 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.Sennosides Sennosides GELATIN GLYCERIN METHYLPARABEN WATER YELLOW WAX FD&C BLUE NO. 1 SOYBEAN OIL SENNOSIDES SENNOSIDES FUMARIC ACID FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID SORBITOL TITANIUM DIOXIDE LECITHIN, SOYBEAN FD&C BLUE NO. 2 FD&C RED NO. 40 Maroon coloured, opaque soft gelatin capsules containing dark brown coloured oily mass.
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.Package Label Principal Display Panel 100ct
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 continues over a period of 2 weeks
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 1-877-770-3183 : weekdays 9:00 AM to 4:30 PM EST.
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 consult 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information ■ store below 30°C and protect from light and moisture
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.Do not use ■ 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