Relief
Sodium Phosphate, Monobasic And Sodium Phosphate, Dibasic, Heptahydrate
Leosons Overseas Corp
Human Otc Drug
NDC 69626-0084Relief also known as Sodium Phosphate, Monobasic And Sodium Phosphate, Dibasic, Heptahydrate is a human otc drug labeled by 'Leosons Overseas Corp'. National Drug Code (NDC) number for Relief is 69626-0084. This drug is available in dosage form of Enema. The names of the active, medicinal ingredients in Relief drug includes Sodium Phosphate, Dibasic, Heptahydrate - 7 g/133mL Sodium Phosphate, Monobasic - 19 g/133mL . The currest status of Relief drug is Active.
Drug Information:
| Drug NDC: | 69626-0084 |
| 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: | Relief |
| 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: | Sodium Phosphate, Monobasic And Sodium Phosphate, Dibasic, Heptahydrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Leosons Overseas Corp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Enema |
| 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: | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE - 7 g/133mL
SODIUM PHOSPHATE, MONOBASIC - 19 g/133mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RECTAL
|
| 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: | 09 Feb, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 2026 |
| 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: | Leosons Overseas Corp
|
| 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. |
| UNII: | 70WT22SF4B
3980JIH2SW
|
| 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 |
|---|
| 69626-0084-6 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69626-0084-6) / 133 mL in 1 BOTTLE, WITH APPLICATOR | 09 Feb, 2015 | 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:
Active ingredients (in each 118 ml delivered dose) purpose monobasic sodium phosphate 19 g............................................... saline laxative dibasic sodium phosphate 7 g....................................................... saline laxative
Product Elements:
Relief sodium phosphate, monobasic and sodium phosphate, dibasic, heptahydrate benzalkonium chloride edetate disodium water sodium phosphate, monobasic phosphate ion sodium phosphate, dibasic, heptahydrate phosphate ion
Indications and Usage:
Use for relief of occasional constipation
Warnings:
Warnings for rectal use only dosage warning: using more than one enema in 24 hours can be harmful. ask a doctor before using this product if you are on a sodium-restricted diet have kidney disease are 65 or older and under a doctor's care for any medical condition ask a doctor before using any laxative if you have abdominal pain, nausea, or vomiting a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week stop use and ask a doctor if you have rectal bleeding no bowel movement within 30 minutes of enema use symptoms of dehydration (feeling thirsty, dizziness, vomiting, urinating less often than normal) these symptoms may indicate a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings and Cautions:
Dosage warning: using more than one enema in 24 hours can be harmful.
Dosage and Administration:
Directions single daily dosage. do not use more unless directed by a doctor. see warnings . do not use if taking another sodium phosphates product. adults and children 12 years and over 1 bottle children 2 to under 12 years 1/2 bottle once daily children under 2 years do not use
Stop Use:
Stop use and ask a doctor if you have rectal bleeding no bowel movement within 30 minutes of enema use symptoms of dehydration (feeling thirsty, dizziness, vomiting, urinating less often than normal) these symptoms may indicate a serious condition.
Package Label Principal Display Panel:
Principal display panel - 133 ml bottle carton relief ⢠saline laxative ready-to-use enema for relief of occasional constipation pre-mixed latex free lubricated tip 1 bottle 4.5 fl oz (133ml) principal display panel - 133 ml bottle carton
Further Questions:
Questions? call toll-free at +1-855-452-9500 or email info@leosonsintl.com