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 g stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) th...
store at 20° - 25°C (68° - 77°F) tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Drug Facts
Polyethylene Glycol 3350, 17 g (cup filled to the indicated "17 GRAMS" line)
Osmotic Laxative
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 or pharmacist before use if you are taking a prescription drug
When using this product you may have loose, watery, more frequent stools
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.
none
call: 1-800-367-3395
Manufactured by:
LGM Pharma Solutions, LLC
Irvine, CA 92614
Distributed by:
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037
NDC 51991-961-58
Polyethylene Glycol
3350, NF
Powder for Solution,
Osmotic Laxative
NET WT. 8.3 OZ (238 g)
14 ONCE - DAILY DOSES
breckenridge
A Towa
Company
NDC 51991-962-57
Polyethylene Glycol
3350, NF
Powder for Solution,
Osmotic Laxative
NET WT 17.9 OZ (510 g)
30 ONCE - DAILY DOSES
breckenridge
A Towa
Company
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51991-961-58 | GM - Gram | 51991-961 | 2855f3fe-9049-4fe9-9179-0986247b2771 | 1 | 2019-07-02 |
| 51991-962-57 | GM - Gram | 51991-962 | c81a1d5c-2ee6-42f1-bea6-becc5c3ae4f5 | 1 | 2019-07-02 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51991-961 | 51991-961-58 |
| 51991-962 | 51991-962-57 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | ACTIB |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | c2088c7a36db… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| 5f8f9f53-2c72-4a5c-9e50-894154140bcc | 2b97ad05-989e-47b4-bb9a-60139c13d33b | 2022-10-04 | Warnings | 5f8f9f53-2c72-4a5c-9e50-894154140bcc 2b97ad05-989e-47b4-bb9a-60139c13d33b |
Adverse event summaries are temporarily unavailable. Other product information remains available.