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NDC 57896-0490-07 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 Gericare Pharmaceuticals. The primary component is POLYETHYLENE GLYCOL 3350.
Product Information
| NDC | 57896-0490 |
|---|---|
| Product ID | 57896-490_f0c44850-fe07-4c48-bb9c-ded2c7fb822b |
| Associated GPIs | |
| GCN Sequence Number | 034313 |
| GCN Sequence Number Description | polyethylene glycol 3350 POWD PACK 17 G ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 86211 |
| HICL Sequence Number | 022819 |
| HICL Sequence Number Description | POLYETHYLENE GLYCOL 3350 |
| Brand/Generic | Generic |
| 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 | Gericare Pharmaceuticals |
| Pharmaceutical Class | Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203928 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 57896-0490-07 (57896049007)
| NDC Package Code | 57896-490-07 |
|---|---|
| Billing NDC | 57896049007 |
| Package | 119 g in 1 CAN (57896-490-07) |
| Marketing Start Date | 2022-10-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd Details
Active ingredient (in each dose)
Use
Warnings
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
Directions
- 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 the 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
Other Information
SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
- Dissolves in any beverage
- Sugar Free
1 DOSE
NET WT 0.5 OZ (17 g)
30 PACKETS
NET WT 0.5 OZ (17 g) Each
7 ONCE-DAILY DOSES
NET WT 4.15 OZ (119 g)
14 ONCE-DAILY DOSES
NET WT 8.3 OZ (238 g)
30 ONCE-DAILY DOSES
NET WT 17.9 OZ (510 g)
45 ONCE-DAILY DOSES
NET WT 26.9 OZ (765 g)
INGREDIENTS AND APPEARANCE
| POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solution |
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| Labeler - Gericare Pharmaceuticals (611196254) |
Revised: 10/2022
Document Id: f0c44850-fe07-4c48-bb9c-ded2c7fb822b
Set id: 5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd
Version: 5
Effective Time: 20221028