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| Product NDC Code | 84324-012 | ||||
|---|---|---|---|---|---|
| Drug Name | Senna laxative |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 312935 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | NUVICARE LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient 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. age starting dosage maximum dosage adults & children 12 years of age 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 1 /2 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 Colloidal silicon dioxide,croscarmellose sodium, Dicalcium phosphate, Hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, Maltodextrin, Purified water, Sodium lauryl sulphate, Stearic Acid.
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 in 6 to 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.Senna Laxative Sennosides 8.6 mg SODIUM LAURYL SULFATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE STEARIC ACID D7 PARAFFIN SENNOSIDES SENNOSIDES DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CROSCARMELLOSE SODIUM none
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.PL0211-00 NC-Senna Natural-Senokot-200ct
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 (1-800-222-1222) 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 store at 20-25°C (68-77°F) excursions permitted between15°-30°C (59°-86°F) each tablet contains: Calcium 25 mg & sodium 3 mg
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 (718) 337-8733 or visit: [email protected]
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.
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: 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