SPL PATIENT PACKAGE INSERT SECTION
GIALAX
- Manufacturer
- Phlight Pharma, LLC
- Effective date
- 2018-12-18
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:33:13
Label at a glance#
ProductGIALAX
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure2 sections
Label contents#
Full prescribing information#
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70569-840-01 | 2025-05-13 | C162847 | 48780-1 | 9d75b9d0-484c-f424-e053-dadaa90a57ce | GIALAX |
| 70569-840-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-484c-f424-e053-dadaa90a57ce | GIALAX |
Products#
Every source-derived product name is available through these pages.
- GIALAX
- Polyethylene Glycol 3350
- All Sport Mix
- Sport Drink Mix
- ASCORBIC ACID
- XANTHAN GUM
- PIGMENT BLUE 1
- ASPARTAME
- SODIUM CHLORIDE
- POTASSIUM CITRATE
- MALTODEXTRIN
- ACESULFAME POTASSIUM
- CALCIUM SILICATE
- ANHYDROUS CITRIC ACID
- MONOPOTASSIUM PHOSPHITE
- FD&C YELLOW NO. 5
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70569-840 | 70569-840-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | ACTIB |
| ASCORBIC ACID | PQ6CK8PD0R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| PIGMENT BLUE 1 | 4SBE571RQF | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| POTASSIUM CITRATE | EE90ONI6FF | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| CALCIUM SILICATE | S4255P4G5M | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| MONOPOTASSIUM PHOSPHITE | 59RSS63D8J | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 33de239d-e420-be56-e063-6394a90ac78a | 321e94ba-4ba9-4392-e054-00144ff88e88 | 2025-04-28 | 321e94ba-4ba9-4392-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.