Polyethylene Glycol 3350
Strides Pharma Inc
Human Otc Drug
NDC 59556-762Polyethylene Glycol 3350 is a human otc drug labeled by 'Strides Pharma Inc'. National Drug Code (NDC) number for Polyethylene Glycol 3350 is 59556-762. This drug is available in dosage form of Powder, For Solution. The names of the active, medicinal ingredients in Polyethylene Glycol 3350 drug includes Polyethylene Glycol 3350 - 17 g/17g . The currest status of Polyethylene Glycol 3350 drug is Active.
Drug Information:
| Drug NDC: | 59556-762 |
| 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: | Polyethylene Glycol 3350 |
| 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: | Polyethylene Glycol 3350 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Strides Pharma Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder, For Solution |
| 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: | POLYETHYLENE GLYCOL 3350 - 17 g/17g
|
| 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: | ANDA |
| 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: | 25 Aug, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | ANDA203928 |
| 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: | Strides Pharma Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 876193
|
| 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. |
| UPC: | 0359556762055
|
| UPC stands for Universal Product Code. |
| NUI: | N0000010288
N0000175811
N0000009871
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | G2M7P15E5P
|
| 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. |
| Pharmacologic Class MOA: | Osmotic Activity [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Osmotic Laxative [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 59556-762-01 | 10 PACKET in 1 CARTON (59556-762-01) / 17 g in 1 PACKET (59556-762-00) | 25 Aug, 2016 | N/A | No |
| 59556-762-02 | 24 PACKET in 1 CARTON (59556-762-02) / 17 g in 1 PACKET (59556-762-00) | 25 Aug, 2016 | N/A | No |
| 59556-762-03 | 119 g in 1 CAN (59556-762-03) | 25 Aug, 2016 | N/A | No |
| 59556-762-04 | 238 g in 1 CAN (59556-762-04) | 25 Aug, 2016 | N/A | No |
| 59556-762-05 | 510 g in 1 CAN (59556-762-05) | 25 Aug, 2016 | 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 ingredient (in each dose) (packet only) polyethylene glycol 3350, 17 g
Product Elements:
Polyethylene glycol 3350 polyethylene glycol 3350 polyethylene glycol 3350 polyethylene glycol 3350 colorless upon dissolution
Indications and Usage:
Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
Warnings:
Warnings allergy alert : do not use if you are allergic to polyethylene glycol do not use if you have kidney disease, except under the advice and supervision of a doctor ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome ask a doctor or pharmacist before use if you are taking a prescription drug when using this product you may have loose, watery, more frequent stools stop use and ask a doctor if you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. these may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week if pregnant or breast-feeding, ask a health professional before use. keep out of the reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings allergy alert : do not use if you are allergic to polyethylene glycol do not use if you have kidney disease, except under the advice and supervision of a doctor ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome ask a doctor or pharmacist before use if you are taking a prescription drug when using this product you may have loose, watery, more frequent stools stop use and ask a doctor if you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. these may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week if pregnant or breast-feeding, ask a health professional before use. keep out of the reach of children. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product you may have loose, watery, more frequent stools
Dosage and Administration:
Directions (can only) do not take more than directed unless advised by your doctor the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap) adults and children 17 years of age and older: use once a day fill to top of white section in cap which is marked to indicate the correct dose (17 g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use more than 7 days children 16 years of age or under: ask a doctor directions (packet only) do not take more than directed unless advised by your doctor adults and children 17 years of age and older: use once a day stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with starch-ba
Read more...sed thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use more than 7 days children 16 years of age or under: ask a doctor
Package Label Principal Display Panel:
Package label.principal display panel 10 packets ndc 59556-762-01 polyethylene glycol 3350 powder for solution osmotic laxative relieves occasional constipation (irregularity) softens stool tamper-evident: do not use if foil is open or broken unflavored sugar free dissolves in any beverage 10 once-daily doses 10 packets net wt 0.5 oz (17g) each 10s carton 10 packets in a carton
Package label.principal display panel 24 packets ndc 59556-762-02 polyethylene glycol 3350 powder for solution osmotic laxative relieves occasional constipation (irregularity) softens stool tamper-evident: do not use if foil is open or broken unflavored sugar free dissolves in any beverage 24 once-daily doses 24 packets net wt 0.5 oz (17g) each 24s carton 24 packets in a carton
Package label.principal display panel ndc 59556-762-00 original prescription strength polyethylene glycol 3350 powder for solution osmotic laxative relieves occasional constipation (irregularity) softens stool tamper-evident: do not use if foil is open or broken unflavored sugar free dissolves in any beverage 1 dose net wt 0.5 oz (17 g) packet packet
Package label.principal display panel ndc 59556-762-03 original prescription strength polyethylene glycol 3350 powder for solution osmotic laxative relieves occasional constipation (irregularity) softens stool tamper-evident: do not use if printed foil seal under cap is missing, open or broken unflavored sugar free dissolves in any beverage 7 once-daily doses net wt 4.15 oz (119 g) 119 g can - front 119 g back [can] 119g back [can] 119g back [can] 119g back [can] 119 g can - front 119 g base label 119g back label 119g back label 119g back label
Package label.principal display panel ndc 59556-762-04 original prescription strength polyethylene glycol 3350 powder for solution osmotic laxative relieves occasional constipation (irregularity) softens stool tamper-evident: do not use if printed foil seal under cap is missing, open or broken unflavored sugar free dissolves in any beverage 14 once-daily doses net wt 8.3 oz (238 g) 238 g can - front 238 g can - back 238 g can - back 238 g front label 238g back label can - back label
Package label.principal display panel ndc 59556-762-05 original prescription strength polyethylene glycol 3350 powder for solution osmotic laxative relieves occasional constipation (irregularity) softens stool tamper-evident: do not use if printed foil seal under cap is missing, open or broken unflavored sugar free dissolves in any beverage 30 once-daily doses net wt 17.9 oz (510 g) 510 g can - front 510 g can - back 510 g front label can - back
Further Questions:
Questions or comments? 1-877-244-9825 polyethylene glycol 3350 powder for solution increases frequency of bowel movements and softens the stool. manufactured by: strides pharma science limited bengaluru â 5562106, india. distributed by strides pharma inc. east brunswick, nj 08816