Indications and uses
• Relieves occasional constipation (irregularity). • Generally, produces a bowel movement in 1 to 3 days.
• Relieves occasional constipation (irregularity). • Generally, produces a bowel movement in 1 to 3 days.
• D o not take more than directed unless advised by your doctor. • The bottle cap is a measuring cup designed to contain 17 grams of powder when filled to the top rim. • Adults and children 17 years of age and older: • Fill to the top of the bottle cap which will provide the correct dose (17 g). • Stir and dissolve in any 4 to 8 ounces of beverage (cold, hot, or room temperature), then drink. • Ensure that the pow...
Polyethylene Glycol 3350, 17 grams (cap filled to the top)
Osmotic Laxative
In case of overdose, get medical help or contact a Poison Control Center right away.
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:
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:
If pregnant or breast-feeding, ask a health professional before use.
Children 16 years of age or younger, ask a doctor.
None.
For serious adverse events call Nexgen Pharma, Inc. at 1-888-710-0006 or contact online at
www.nexgenpharma.com.
Manufactured by: Nexgen Pharma, Inc., Irvine, CA 92606, USA
Rev. 09/2019
| Class | Version | Type | Effective |
|---|---|---|---|
| POLYETHYLENE GLYCOL 3350 Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0722-7116-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3318-a910-e053-dadaa90a0b85 | Drug Facts |
| 0722-7116-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3318-a910-e053-dadaa90a0b85 | Drug Facts |
| 0722-7116-03 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3318-a910-e053-dadaa90a0b85 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0722-7116-01 | Polyethylene Glycol 3350, NF Powder for Solution, Laxative | 7 d in 1 BOTTLE | POWDER, FOR SOLUTION | 7 | 2 | |
| 0722-7116-02 | Polyethylene Glycol 3350, NF Powder for Solution, Laxative | 14 d in 1 BOTTLE | POWDER, FOR SOLUTION | 14 | 2 | |
| 0722-7116-03 | Polyethylene Glycol 3350, NF Powder for Solution, Laxative | 30 d in 1 BOTTLE | POWDER, FOR SOLUTION | 30 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0722-7116-01 | GM - Gram | 0722-7116 | 473bc880-16df-4d3b-a436-1b55a5f6f9da | 1 | 2012-07-24 |
| 0722-7116-02 | GM - Gram | 0722-7116 | 597d615e-874a-429e-956c-cbfd90d0e208 | 1 | 2012-07-24 |
| 0722-7116-03 | GM - Gram | 0722-7116 | bb77f060-d264-454f-a02b-58e8a83a882b | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| POLYETHYLENE GLYCOL 3350 | ACTIVE INGREDIENT | G2M7P15E5P | 1 | |
| POLYETHYLENE GLYCOL 3350 | ACTIVE MOIETY | G2M7P15E5P | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0722-7116 | 0722-7116-01, 0722-7116-02, 0722-7116-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | ACTIB |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090812-001 | POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1004c7e3-4b55-456a-b2ab-bd14242769c9 | d6218f65-1b41-417e-b928-56ac6db411af | 2019-09-04 | Warnings | 1004c7e3-4b55-456a-b2ab-bd14242769c9 d6218f65-1b41-417e-b928-56ac6db411af |
Adverse event summaries are temporarily unavailable. Other product information remains available.