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| Product NDC Code | 51824-058 | ||||
|---|---|---|---|---|---|
| Drug Name | Careall sennosides |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 312935 | ||||
| Application Number | M007 | ||||
| Labeler Name | New World Imports, Inc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Sennosides
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 over 12 years: 2 tablets once a day. Maximum of 4 tablets twice a day. Children 6 to under 12 years: 1 tablet once a day. Maximum of 2 tablets twice a day. Children 2 to under 6 years: 1/2 tablet once a day. Maximum of 1 tablet twice a day. Children under 2: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients croscarmellose sodium, dibasic dicalcium phosphate, magnesium stearate, microcrystalline cellulose, and silicon 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 For relief of occasional constipation and irregularity. This product 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.CAREALL Sennosides Sennosides sennosides a and b SENNOSIDES A AND B SILICON DIOXIDE Croscarmellose Sodium DIBASIC CALCIUM PHOSPHATE DIHYDRATE Magnesium stearate Cellulose, microcrystalline Speckled various shades of brown Round AZ;217
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.SEN100 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 Reach of Children In case of accidental overdose, contact a doctor or Poison Control Center immediately.
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 more than one week unless directed by a doctor Ask a doctor before use if you have stomach pains, nausea, vomiting, notice a sudden change in bowel habits that continues over a period of 2 weeks. Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative. These could be signs of a serious condition. If Pregnant or breast-feeding ask a health professional before use.
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