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| Product NDC Code | 36800-270 | ||||
|---|---|---|---|---|---|
| Drug Name | Top care castor oil |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | OIL | ||||
| RxCUI drug identifier | 204691 | ||||
| Application Number | M007 | ||||
| Labeler Name | TOPCO ASSOCIATES LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Castor Oil
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.Preferably take on an empty stomach. May be taken with juice to improve taste. Adults and children 12 yrs. of age and older: 15 to 60 milliliters in a single daily dose or as directed by a doctor. Children 2 to under 12 yrs. of age: 5 to 15 milliliters in a single dose or as directed by a doctor. Children under 2 yrs. of age: Consult a doctor before use. Changed 1 to 4 tablesponfuls to 15 to 60 milliliters, changed 1 to 3 teaspoonfuls to 5 to 15 milliliters. (6/2021)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.None
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.For relief of occasional constipation. Bowel movement is generally produced in 6 to 12 hours.
Purpose
Information about the drug product’s indications for use.Stimulant Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Top Care Castor Oil Castor Oil WATER CASTOR OIL CASTOR OIL
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.Top Care Castor Oil TC Castor Oil.jpg
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Changed 1 to 4 tablesponfuls to 15 to 60 milliliters, changed 1 to 3 teaspoonfuls to 5 to 15 milliliters. (6/2021)
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.In case of accidental overdose, seek profssional assistance or contact a 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.Do not use when abdominal pain, nausea, or vomiting are present 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