Oral Saline Laxative Lemon Ginger
Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form
Natureplex, Llc
Human Otc Drug
NDC 67234-044Oral Saline Laxative Lemon Ginger also known as Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form is a human otc drug labeled by 'Natureplex, Llc'. National Drug Code (NDC) number for Oral Saline Laxative Lemon Ginger is 67234-044. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Oral Saline Laxative Lemon Ginger drug includes Sodium Phosphate, Dibasic, Unspecified Form - 1.4 g/14.7868mL Sodium Phosphate, Monobasic, Unspecified Form - 6.2 g/14.7868mL . The currest status of Oral Saline Laxative Lemon Ginger drug is Active.
Drug Information:
| Drug NDC: | 67234-044 |
| 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: | Oral Saline Laxative Lemon Ginger |
| 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, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Natureplex, Llc |
| 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: | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM - 1.4 g/14.7868mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM - 6.2 g/14.7868mL
|
| 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: | 30 May, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 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: | Natureplex, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1790675
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | GR686LBA74
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 |
|---|
| 67234-044-01 | 1 BOTTLE in 1 CARTON (67234-044-01) / 45 mL in 1 BOTTLE | 30 May, 2012 | 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 tablespoon) purpose dibasic sodium phosphate 2.7g saline laxative monobasic sodium phosphate 7.2g saline laxative
Product Elements:
Oral saline laxative lemon ginger sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form sodium phosphate, dibasic, unspecified form phosphate ion sodium cation sodium phosphate, monobasic, unspecified form phosphate ion sodium cation glycerin water saccharin sodium sodium benzoate
Indications and Usage:
Use relieves occasional constipation this product generally produces bowel movement in 30 minutes to 6 hours
Warnings:
Warnings dosage warning taking more than the recommended dosage in 24 hours can be harmful. do not use if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, or uncorrected electrolyte abnormalities in children under 6 years old for bowel cleansing ask a doctor before use if you have abdominal pain, nausea, or vomiting have kidney disease have heart problems have a sudden change in bowel habits lasting more than 2 weeks have already used a laxative for more than 3 days are dehydrated are 55 years of age or older are on a sodium-restricted diet under a doctor's care for any medical condition are taking any other prescription or non-prescription medications ask a doctor or pharmacist before use if you are taking any other drug. take this product two or more hours before or after other drugs. laxatives may affect how other drugs work. when using this product do not use more than directed. serious side effects
Read more... may occur from excess dosage. do not use for more than 3 days, without asking a doctor stop use and ask a doctor if you have rectal bleeding you do not have a bowel movement within 6 hours you have any symptoms that your body is losing more fluid than you are drinking you have early symptoms of dehydration including thirstiness dizziness urinating less often than normal vomiting these symptoms may indicate a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away: 800-222-1222.
Do Not Use:
Warnings dosage warning taking more than the recommended dosage in 24 hours can be harmful. do not use if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, or uncorrected electrolyte abnormalities in children under 6 years old for bowel cleansing ask a doctor before use if you have abdominal pain, nausea, or vomiting have kidney disease have heart problems have a sudden change in bowel habits lasting more than 2 weeks have already used a laxative for more than 3 days are dehydrated are 55 years of age or older are on a sodium-restricted diet under a doctor's care for any medical condition are taking any other prescription or non-prescription medications ask a doctor or pharmacist before use if you are taking any other drug. take this product two or more hours before or after other drugs. laxatives may affect how other drugs work. when using this product do not use more than directed. serious side effects may occur from excess dosage. do not use for more than 3 days, without asking a doctor stop use and ask a doctor if you have rectal bleeding you do not have a bowel movement within 6 hours you have any symptoms that your body is losing more fluid than you are drinking you have early symptoms of dehydration including thirstiness dizziness urinating less often than normal vomiting these symptoms may indicate a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away: 800-222-1222.
When Using:
When using this product do not use more than directed. serious side effects may occur from excess dosage. do not use for more than 3 days, without asking a doctor
Dosage and Administration:
Directions (or as directed by a doctor) use as a laxative for relief of occasional constipation dilute dose in the table below with one glass (8 fl oz) of cool water. drink, then follow with at least one additional glass (8 fl oz) of cool water. there is significant loss of fluid when using this product. to prevent dehydration, drink plenty of clear liquids after use. do not use for bowel cleansing there are 3 teaspoons in 1 tablespoon do not take more unless directed by a doctor. see warnings ages (years) dosage maximum dose 12 and older 1 tablespoon 2 to 3 tablespoons single daily dosage. do not take more of this product in a 24-hour period 10 to 11 1 tablespoon 1 tablespoon 6 to 9 1 teaspoons 2 teaspoons under 6 ask a doctor ask a doctor
Stop Use:
Stop use and ask a doctor if you have rectal bleeding you do not have a bowel movement within 6 hours you have any symptoms that your body is losing more fluid than you are drinking you have early symptoms of dehydration including thirstiness dizziness urinating less often than normal vomiting these symptoms may indicate a serious condition.
Package Label Principal Display Panel:
Principal display panel - 45 ml bottle carton â for directions lift side panel natureplex ⢠oral saline laxative phosphate for relief of occasional constipation ndc 67234-044-01 lemon ginger 1.5 fl oz (45 ml) principal display panel - 45 ml bottle carton
Further Questions:
Questions or comments? 866-323-0107 or www.natureplex.com