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NDC 58602-0805-04 Polyethylene Glycol 3350 17 g/17g Details
Polyethylene Glycol 3350 17 g/17g
Polyethylene Glycol 3350 is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is POLYETHYLENE GLYCOL 3350.
MedlinePlus Drug Summary
Polyethylene glycol 3350 is used to treat occasional constipation. Polyethylene glycol 3350 is in a class of medications called osmotic laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.
Related Packages: 58602-0805-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350
Product Information
| NDC | 58602-0805 |
|---|---|
| Product ID | 58602-805_3e8f5acd-e6b3-405d-afb3-b94691c522fe |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Polyethylene Glycol 3350 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Polyethylene Glycol 3350 |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 17 |
| Active Ingredient Units | g/17g |
| Substance Name | POLYETHYLENE GLYCOL 3350 |
| Labeler Name | Aurohealth LLC |
| Pharmaceutical Class | Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209017 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 58602-0805-04 (58602080504)
| NDC Package Code | 58602-805-04 |
|---|---|
| Billing NDC | 58602080504 |
| Package | 850 g in 1 BOTTLE, PLASTIC (58602-805-04) |
| Marketing Start Date | 2018-04-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d3c77f3f-57aa-4e2d-88aa-731cbb22af70 Details
Drug Facts
Use
SPL UNCLASSIFIED SECTION
Ask a doctor before use if you have
SPL UNCLASSIFIED SECTION
Stop use and ask a doctor if
Keep out of reach of children.
Directions
- do not take more than directed unless advised by your doctor
- this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
- adults and children 17 years of age and older:
- use once a day
- fill to the indicated 17 grams line on cup which is marked to indicate the correct dose 17 grams
- 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 no more than 7 days
- children 16 years of age or under: ask a doctor
Other information
Inactive ingredients
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label
INGREDIENTS AND APPEARANCE
| POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solution |
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| Labeler - Aurohealth LLC (078728447) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aurobindo Pharma Limited | 918917642 | ANALYSIS(58602-805) , MANUFACTURE(58602-805) | |
Revised: 6/2021
Document Id: 3e8f5acd-e6b3-405d-afb3-b94691c522fe
Set id: d3c77f3f-57aa-4e2d-88aa-731cbb22af70
Version: 4
Effective Time: 20210608