Humco Castor Oil (regular)
Castor Oil
Humco Holding Group, Inc.
Human Otc Drug
NDC 0395-0513Humco Castor Oil (regular) also known as Castor Oil is a human otc drug labeled by 'Humco Holding Group, Inc.'. National Drug Code (NDC) number for Humco Castor Oil (regular) is 0395-0513. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Humco Castor Oil (regular) drug includes Castor Oil - 1 mg/mL . The currest status of Humco Castor Oil (regular) drug is Active.
Drug Information:
| Drug NDC: | 0395-0513 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Humco Castor Oil (regular) |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Castor Oil |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Humco Holding Group, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CASTOR OIL - 1 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jan, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part334 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Humco Holding Group, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0303950513942
|
| UPC stands for Universal Product Code. |
| UNII: | D5340Y2I9G
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0395-0513-94 | 118 mL in 1 BOTTLE (0395-0513-94) | 01 Jan, 2013 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose stimulant laxative
Product Elements:
Humco castor oil (regular) castor oil water castor oil castor oil
Indications and Usage:
Uses for the temporary relief of ocassional constipation. bowel movement is generally produced in 6 to 12 hours.
Warnings:
Warnings do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor.
When Using:
When using this product: discontinue use and consult a doctor if you have rectal bleeding or failure to have a bowel movement after the use of a laxative. these symptoms may indicate a serious condition. if pregnant or breastfeeding ask a health professional before use.
Dosage and Administration:
Directions adults and children 12 yrs. of age and older: 1 to 4 tablespoonfuls in a single day or as directed by a doctor. children 2 to under 12 years of age: 1 to 3 teasponfuls in a signle daily dose or as directed by a doctor. children under 2 yrs. of age: consult a doctor before use.
Stop Use:
Ask a doctor before use. if you have noticed a sudden change in bowel habits that persists over a period of two weeks. laxative products should not be used for a period of longer than 1 week unless directed by a doctor. frequent or prolonged use may result in dependence on laxatives.
Package Label Principal Display Panel:
Label image description